Title

A Phase I Dose-escalation Study of Subcutaneous ALM201 in Patients With Advanced Ovarian Cancer and Other Solid Tumours
A Phase I Open-label Multicentre Dose-escalation Study of Subcutaneous ALM201 in Patients With Advanced Ovarian Cancer and Other Solid Tumours
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Intervention/Treatment

    ALM201
  • Study Participants

    20
ALM201/0001 is a Phase I, open-label, dose-escalation study of the safety, tolerability and pharmacokinetics (PK) of ALM201.

Part 1 will be a dose-escalation study. Patients with advanced solid tumours will receive daily doses of ALM201 on Days 1-5, 8-12 and 15-19 in 21 day cycles.

Part 2 will be a dose-expansion of the Maximum Tolerated Dose (MTD) determined in Part 1. Patients with advanced ovarian cancer will be enrolled with the main objective to determine the recommended Phase II dose.
ALM201 is a peptide with anti-angiogenic activity in a range of in-vitro and ex-vivo models. ALM201/0001 is a Phase I, multicentre, open-label, dose-escalation study of the safety, tolerability and pharmacokinetics (PK) of ALM201. The study is divided into two parts.

Part 1 will enrol patients with advanced solid tumours. Patients will receive subcutaneous injection of ALM201 on Days 1-5, 8-12 and 15-19 in 21 day cycles. Patients can receive up to 8 cycles of treatment. Enrolment will follow an accelerated dose-escalation schedule until grade 2 drug-related adverse events are observed, at this point the 3+3 enrolment design will be used. There will be at least 1 week stagger between the first and subsequent patients in a new cohort dose. Dose increments will not exceed 100% escalation and will be guided by data generated from previous cycles. The dose and possibly the schedule will be adjusted to determine the Maximum Tolerated Dose (MTD).

Part 2 will enrol patients with advanced ovarian cancer whose tumour has a proangiogenic profile as assessed by an angiogenesis gene signature biomarker. Patients will receive ALM201 at a dose and schedule established in Part 1.

Patients will undergo safety and tumour assessments as well as blood draws for PK profiling. The safety assessments will involve physical examination, vital signs, biochemistry and haematology laboratory screens as well as immunogenicity testing. Tumour assessments will involve computed tomography (CT) or magnetic resonance imaging (MRI) scans at screening and after every 2 cycles during cycles 1 -8. Patients will be asked to provide consent for access to archived tumour tissue and for fresh biopsies to be taken at pre-dose, tumour response and/or point of disease progression for potential biomarker and pharmacodynamic assessments. PK profiling will be carried out in Cycles 1, 2, 4, 6 and 8.
Study Started
Apr 27
2015
Primary Completion
Mar 13
2017
Study Completion
Mar 13
2017
Results Posted
Sep 11
2019
Last Update
Sep 11
2019

Drug ALM201

Drug: ALM201 administered subcutaneously

Solid tumours Experimental

Part 1 - Dose-escalation of ALM201 in patients with advanced solid tumours Daily dosing of ALM201 on Days 1-5, 8-12 and 15-19 of 21 day cycle. Escalating dose cohorts

Ovarian cancer Experimental

Part 2 - Dose-expansion of ALM201 Maximum Tolerated Dose (MTD) in patients with advanced ovarian cancer Daily dosing of ALM201 on Days 1-5, 8-12 and 15-19 of 21 day cycle at the MTD determined in Part 1

Criteria

Inclusion Criteria:

Part 1 Specific Inclusion Criterion

*Patients with histologically and/or cytologically confirmed advanced solid tumour for whom no standard effective therapy is available or felt likely to be of limited efficacy and in whom a rationale for use of an anti-angiogenic treatment approach exists. Note: Previous use of anti-angiogenic therapy is allowed if tolerated

Part 2 Specific Inclusion Criterion

*Patients with advanced ovarian cancer, who are intolerant of or whose tumour is resistant to platinums and who have failed to respond to, or have relapsed following, standard therapy and whose tumour has a proangiogenic profile as assessed by the angiogenesis gene signature test. Note: Previous use of anti-angiogenic therapy is allowed if tolerated.

General Inclusion Criteria for all Patients

Measurable or evaluable disease.
Recovery from previous treatment to baseline or CTCAE ≤ Grade 1, as determined by CTCAE v4.03 criteria (Appendix B), of reversible toxicities related to prior treatment, with the exception of alopecia, lymphopenia, other non-clinically significant adverse events; recovery from previous radiotherapy other than residual cutaneous effects or stable < Grade 2 gastrointestinal toxicity; complete recovery from surgery other than stable < Grade 2 toxicity.
ECOG Performance Status (PS) of 0 or 1.
Acceptable haematological, renal and hepatic
Women must have either a negative pregnancy test prior to first study drug administration or be post menopausal. Male and female patients of childbearing potential must use appropriate methods birth control.
Patients must give written informed consent and understand the requirements of the study

Exclusion Criteria:

For all Patients

History of inability to tolerate anti-angiogenic therapies e.g. increased blood pressure (BP), proteinuria, prior thromboembolic events.
Previous history of bowel obstruction, clinical evidence of gastro-intestinal obstruction, large burden of peritoneal disease or evidence of bowel involvement on computed tomography.

Patents has received:

any chemotherapy regimens (including investigational agents) with delayed toxicity within 4 weeks (6 weeks for prior nitrosourea or mitomycin C) of Cycle 1, Day 1, or received chemotherapy regimens given continuously or on a weekly basis which have limited potential for delayed toxicity within 2 weeks of Cycle 1, Day 1.
radiotherapy, immunotherapy or biological agents (includes investigational agents) within 4 weeks of Cycle 1, Day 1. Localised palliative radiotherapy is permitted for symptom control.
Documented, symptomatic or uncontrolled intracranial metastases or primary intracerebral tumours.
Cancer with leptomeningeal involvement.
On therapeutic anti-coagulation (aspirin dosing ≤100 mg per oral (PO) daily allowed).
Previous malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, unless the tumour was treated with curative intent more than 2 years prior to study entry.
Active cardiac condition or history of significant cardiac condition. Known human immunodeficiency virus positivity.
Active hepatitis B or C or other active liver disease (other than malignancy).
Any active, clinically significant, viral, bacterial, or systemic fungal infection within 4 weeks prior to Cycle 1, Day 1.
Any evidence of severe or uncontrolled systemic conditions or any other issues which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.

Summary

Cohort 1 - ALM201

Cohort 2 - ALM201

Cohort 3 - ALM201

Cohort 4 - ALM201

Cohort 5 - ALM201

Cohort 6 - ALM201

Cohort 7 - ALM201

Cohort 8 - ALM201

All Events

Event Type Organ System Event Term Cohort 1 - ALM201 Cohort 2 - ALM201 Cohort 3 - ALM201 Cohort 4 - ALM201 Cohort 5 - ALM201 Cohort 6 - ALM201 Cohort 7 - ALM201 Cohort 8 - ALM201

Safety and Tolerability - Evaluation of AEs and DLT

All events and suspected dose limiting toxicities (DLTs) were graded according to the CTCAE, version 4.03. A DLT was defined as a Grade 3 or 4 AE that, in the opinion of the CRC, was likely to be related to ALM201 and represented a clinically significant hazard to the patient. Qualifying DLT events were considered to be clinically relevant; e.g. in duration, apparent reversibility, required management, and upon consideration of the patient's medical history and/or concomitant medications. DLT events were also evaluated in terms of what was considered to be an appropriate next escalation step: In the case where the CRC agreed that an escalation step of approximately 33% or lower was merited; the toxicity of concern could be declared a DLT. In order to be evaluable for DLT assessment, a patient had to receive at least 80% of their scheduled doses (e.g. 12 of the 15), unless this lack of compliance was due to ALM201-related toxicity.

Cohort 1 - ALM201

SAE

TEAE DLT

1.0
participants

TEAE treatment related

1.0
participants

treatment related SAE

1.0
participants

Cohort 2 - ALM201

SAE

TEAE DLT

TEAE treatment related

treatment related SAE

Cohort 3 - ALM201

SAE

TEAE DLT

1.0
participants

TEAE treatment related

1.0
participants

treatment related SAE

Cohort 4 - ALM201

SAE

TEAE DLT

1.0
participants

TEAE treatment related

3.0
participants

treatment related SAE

1.0
participants

Cohort 5 - ALM201

SAE

TEAE DLT

3.0
participants

TEAE treatment related

3.0
participants

treatment related SAE

1.0
participants

Cohort 6 - ALM201

SAE

TEAE DLT

4.0
participants

TEAE treatment related

4.0
participants

treatment related SAE

2.0
participants

Cohort 7 - ALM201

SAE

TEAE DLT

3.0
participants

TEAE treatment related

3.0
participants

treatment related SAE

Cohort 8 - ALM201

SAE

TEAE DLT

2.0
participants

TEAE treatment related

4.0
participants

treatment related SAE

1.0
participants

Tumour Response Assessment - Best Overall Response

As this was a Phase 1 study, the extent of efficacy data was expected to be limited. Using RECIST Version 1.1, a summary of clinical benefit from patients with evaluable disease was generated via CT scans: Complete Response (CR) = Disappearance of all target & non-target lesions + normalization of tumor marker; Partial Response (PR) ≥ 30% decrease in the sum of LD of target lesions; Progressive Disease (PD) ≥ 20% increase (& 5mm absolute increase) in sum of LD of target lesions or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.

Cohort 1 - ALM201

Complete Response (CR)

Disease Control Rate (CR+PR+SD)

1.0
participants

Not Evaluable (NE+NA)

Overall Response Rate (CR+PR)

Partial Response (PR)

Progressive Disease

Stable Disease (SD)

1.0
participants

Cohort 2 - ALM201

Complete Response (CR)

Disease Control Rate (CR+PR+SD)

Not Evaluable (NE+NA)

Overall Response Rate (CR+PR)

Partial Response (PR)

Progressive Disease

1.0
participants

Stable Disease (SD)

Cohort 3 - ALM201

Complete Response (CR)

Disease Control Rate (CR+PR+SD)

1.0
participants

Not Evaluable (NE+NA)

Overall Response Rate (CR+PR)

Partial Response (PR)

Progressive Disease

Stable Disease (SD)

1.0
participants

Cohort 4 - ALM201

Complete Response (CR)

Disease Control Rate (CR+PR+SD)

Not Evaluable (NE+NA)

Overall Response Rate (CR+PR)

Partial Response (PR)

Progressive Disease

3.0
participants

Stable Disease (SD)

Cohort 5 - ALM201

Complete Response (CR)

Disease Control Rate (CR+PR+SD)

Not Evaluable (NE+NA)

Overall Response Rate (CR+PR)

Partial Response (PR)

Progressive Disease

3.0
participants

Stable Disease (SD)

Cohort 6 - ALM201

Complete Response (CR)

Disease Control Rate (CR+PR+SD)

2.0
participants

Not Evaluable (NE+NA)

1.0
participants

Overall Response Rate (CR+PR)

Partial Response (PR)

Progressive Disease

1.0
participants

Stable Disease (SD)

2.0
participants

Cohort 7 - ALM201

Complete Response (CR)

Disease Control Rate (CR+PR+SD)

2.0
participants

Not Evaluable (NE+NA)

Overall Response Rate (CR+PR)

Partial Response (PR)

Progressive Disease

1.0
participants

Stable Disease (SD)

2.0
participants

Cohort 8 - ALM201

Complete Response (CR)

Disease Control Rate (CR+PR+SD)

1.0
participants

Not Evaluable (NE+NA)

Overall Response Rate (CR+PR)

Partial Response (PR)

Progressive Disease

3.0
participants

Stable Disease (SD)

1.0
participants

Pharmacokinetics: Tmax

Tmax was derived from the individual patient plasma concentration versus time profiles of ALM201.

Cohort 1 - ALM201

Cycle 1 - Day 1

1.45
hour (Median)
Full Range: 1.45 to 1.45

Cycle 1 - Day 18

1.58
hour (Median)
Full Range: 1.58 to 1.58

Cycle 1 - Day 3

0.5
hour (Median)
Full Range: 0.5 to 0.5

Cycle 2 - Day 18

2.0
hour (Median)
Full Range: 2.0 to 2.0

Cycle 4 - Day 18

1.53
hour (Median)
Full Range: 1.53 to 1.53

Cycle 6 - Day 18

1.85
hour (Median)
Full Range: 1.85 to 1.85

Cohort 2 - ALM201

Cycle 1 - Day 1

1.5
hour (Median)
Full Range: 1.5 to 1.5

Cycle 1 - Day 18

1.02
hour (Median)
Full Range: 1.02 to 1.02

Cycle 1 - Day 3

1.0
hour (Median)
Full Range: 1.0 to 1.0

Cycle 2 - Day 18

1.0
hour (Median)
Full Range: 1.0 to 1.0

Cohort 3 - ALM201

Cycle 1 - Day 1

1.63
hour (Median)
Full Range: 1.63 to 1.63

Cycle 1 - Day 18

1.0
hour (Median)
Full Range: 1.0 to 1.0

Cycle 1 - Day 3

1.5
hour (Median)
Full Range: 1.5 to 1.5

Cycle 2 - Day 18

1.03
hour (Median)
Full Range: 1.03 to 1.03

Cohort 4 - ALM201

Cycle 1 - Day 1

1.53
hour (Median)
Full Range: 0.75 to 2.0

Cycle 1 - Day 18

1.23
hour (Median)
Full Range: 0.47 to 2.0

Cycle 1 - Day 3

1.5
hour (Median)
Full Range: 1.05 to 2.0

Cycle 2 - Day 18

3.5
hour (Median)
Full Range: 3.5 to 3.5

Cohort 5 - ALM201

Cycle 1 - Day 1

1.52
hour (Median)
Full Range: 0.8 to 3.07

Cycle 1 - Day 18

1.5
hour (Median)
Full Range: 0.5 to 2.0

Cycle 1 - Day 3

1.52
hour (Median)
Full Range: 1.52 to 2.05

Cycle 2 - Day 18

2.0
hour (Median)
Full Range: 2.0 to 2.0

Cohort 6 - ALM201

Cycle 1 - Day 1

2.5
hour (Median)
Full Range: 1.5 to 3.08

Cycle 1 - Day 18

2.03
hour (Median)
Full Range: 1.0 to 3.5

Cycle 1 - Day 3

2.0
hour (Median)
Full Range: 1.48 to 2.0

Cycle 2 - Day 18

1.54
hour (Median)
Full Range: 1.5 to 1.58

Cycle 4 - Day 18

1.57
hour (Median)
Full Range: 1.0 to 2.13

Cohort 7 - ALM201

Cycle 1 - Day 1

2.0
hour (Median)
Full Range: 0.75 to 4.0

Cycle 1 - Day 18

1.5
hour (Median)
Full Range: 1.0 to 2.07

Cycle 1 - Day 3

1.02
hour (Median)
Full Range: 1.0 to 2.0

Cycle 2 - Day 18

2.0
hour (Median)
Full Range: 1.48 to 2.13

Cycle 4 - Day 18

1.12
hour (Median)
Full Range: 1.12 to 1.12

Cycle 6 - Day 18

2.02
hour (Median)
Full Range: 2.02 to 2.02

Cohort 8 - ALM201

Cycle 1 - Day 1

1.5
hour (Median)
Full Range: 1.3 to 1.5

Cycle 1 - Day 18

1.9
hour (Median)
Full Range: 1.45 to 2.35

Cycle 1 - Day 3

1.61
hour (Median)
Full Range: 0.5 to 2.02

Cycle 2 - Day 18

1.02
hour (Median)
Full Range: 1.02 to 1.02

Pharmacokinetics: AUC 0-t

AUC 0-t was derived from the individual patient plasma concentration versus time profiles of ALM201.

Cohort 4 - ALM201

Cycle 1 - Day 1

3380.0
ng*h/mL (Geometric Mean)
Full Range: 3100.0 to 3790.0

Cycle 1 - Day 18

3500.0
ng*h/mL (Geometric Mean)
Full Range: 3440.0 to 3570.0

Cycle 1 - Day 3

2970.0
ng*h/mL (Geometric Mean)
Full Range: 2660.0 to 3430.0

Cycle 2 - Day 18

3230.0
ng*h/mL (Geometric Mean)
Full Range: 3230.0 to 3230.0

Cohort 5 - ALM201

Cycle 1 - Day 1

6510.0
ng*h/mL (Geometric Mean)
Full Range: 5600.0 to 7560.0

Cycle 1 - Day 18

4930.0
ng*h/mL (Geometric Mean)
Full Range: 4400.0 to 5400.0

Cycle 1 - Day 3

5100.0
ng*h/mL (Geometric Mean)
Full Range: 4970.0 to 5280.0

Cycle 2 - Day 18

5710.0
ng*h/mL (Geometric Mean)
Full Range: 5710.0 to 5710.0

Cohort 6 - ALM201

Cycle 1 - Day 1

5860.0
ng*h/mL (Geometric Mean)
Full Range: 3460.0 to 10200.0

Cycle 1 - Day 18

5570.0
ng*h/mL (Geometric Mean)
Full Range: 3900.0 to 10000.0

Cycle 1 - Day 3

6630.0
ng*h/mL (Geometric Mean)
Full Range: 4460.0 to 11900.0

Cycle 2 - Day 18

5680.0
ng*h/mL (Geometric Mean)
Full Range: 3810.0 to 8480.0

Cycle 4 - Day 18

6110.0
ng*h/mL (Geometric Mean)
Full Range: 4150.0 to 9010.0

Cohort 7 - ALM201

Cycle 1 - Day 1

11900.0
ng*h/mL (Geometric Mean)
Full Range: 9470.0 to 15100.0

Cycle 1 - Day 18

12100.0
ng*h/mL (Geometric Mean)
Full Range: 11400.0 to 12900.0

Cycle 1 - Day 3

12500.0
ng*h/mL (Geometric Mean)
Full Range: 10500.0 to 14700.0

Cycle 2 - Day 18

10400.0
ng*h/mL (Geometric Mean)
Full Range: 7290.0 to 16700.0

Cycle 4 - Day 18

8600.0
ng*h/mL (Geometric Mean)
Full Range: 8600.0 to 8600.0

Cycle 6 - Day 18

26700.0
ng*h/mL (Geometric Mean)
Full Range: 26700.0 to 26700.0

Cohort 8 - ALM201

Cycle 1 - Day 1

6280.0
ng*h/mL (Geometric Mean)
Full Range: 1140.0 to 14800.0

Cycle 1 - Day 18

8100.0
ng*h/mL (Geometric Mean)
Full Range: 7000.0 to 9370.0

Cycle 1 - Day 3

8870.0
ng*h/mL (Geometric Mean)
Full Range: 5380.0 to 12800.0

Cycle 2 - Day 18

5930.0
ng*h/mL (Geometric Mean)
Full Range: 5930.0 to 5930.0

Cohort 1 - ALM201

Cycle 1 - Day 1

485.0
ng*h/mL (Geometric Mean)
Full Range: 485.0 to 485.0

Cycle 1 - Day 18

817.0
ng*h/mL (Geometric Mean)
Full Range: 817.0 to 817.0

Cycle 1 - Day 3

868.0
ng*h/mL (Geometric Mean)
Full Range: 868.0 to 868.0

Cycle 2 - Day 18

702.0
ng*h/mL (Geometric Mean)
Full Range: 702.0 to 702.0

Cycle 4 - Day 18

476.0
ng*h/mL (Geometric Mean)
Full Range: 476.0 to 476.0

Cycle 6 - Day 18

1040.0
ng*h/mL (Geometric Mean)
Full Range: 1040.0 to 1040.0

Cohort 2 - ALM201

Cycle 1 - Day 1

1040.0
ng*h/mL (Geometric Mean)
Full Range: 1040.0 to 1040.0

Cycle 1 - Day 18

718.0
ng*h/mL (Geometric Mean)
Full Range: 718.0 to 718.0

Cycle 1 - Day 3

1160.0
ng*h/mL (Geometric Mean)
Full Range: 1160.0 to 1160.0

Cycle 2 - Day 18

1020.0
ng*h/mL (Geometric Mean)
Full Range: 1020.0 to 1020.0

Cohort 3 - ALM201

Cycle 1 - Day 1

1920.0
ng*h/mL (Geometric Mean)
Full Range: 1920.0 to 1920.0

Cycle 1 - Day 18

1840.0
ng*h/mL (Geometric Mean)
Full Range: 1840.0 to 1840.0

Cycle 1 - Day 3

898.0
ng*h/mL (Geometric Mean)
Full Range: 898.0 to 898.0

Cycle 2 - Day 18

1950.0
ng*h/mL (Geometric Mean)
Full Range: 1950.0 to 1950.0

Pharmacokinetics: Cmax

Cmax was derived from the individual patient plasma concentration of ALM201.

Cohort 1 - ALM201

Cycle 1 - Day 1

200.0
ng/mL (Geometric Mean)
Full Range: 200.0 to 200.0

Cycle 1 - Day 18

352.0
ng/mL (Geometric Mean)
Full Range: 352.0 to 352.0

Cycle 1 - Day 3

406.0
ng/mL (Geometric Mean)
Full Range: 406.0 to 406.0

Cycle 2 - Day 18

288.0
ng/mL (Geometric Mean)
Full Range: 288.0 to 288.0

Cycle 4 - Day 18

193.0
ng/mL (Geometric Mean)
Full Range: 193.0 to 193.0

Cycle 6 - Day 18

470.0
ng/mL (Geometric Mean)
Full Range: 470.0 to 470.0

Cohort 2 - ALM201

Cycle 1 - Day 1

542.0
ng/mL (Geometric Mean)
Full Range: 542.0 to 542.0

Cycle 1 - Day 18

319.0
ng/mL (Geometric Mean)
Full Range: 319.0 to 319.0

Cycle 1 - Day 3

614.0
ng/mL (Geometric Mean)
Full Range: 614.0 to 614.0

Cycle 2 - Day 18

394.0
ng/mL (Geometric Mean)
Full Range: 394.0 to 394.0

Cohort 3 - ALM201

Cycle 1 - Day 1

592.0
ng/mL (Geometric Mean)
Full Range: 592.0 to 592.0

Cycle 1 - Day 18

405.0
ng/mL (Geometric Mean)
Full Range: 405.0 to 405.0

Cycle 1 - Day 3

759.0
ng/mL (Geometric Mean)
Full Range: 759.0 to 759.0

Cycle 2 - Day 18

583.0
ng/mL (Geometric Mean)
Full Range: 583.0 to 583.0

Cohort 4 - ALM201

Cycle 1 - Day 1

835.0
ng/mL (Geometric Mean)
Full Range: 749.0 to 892.0

Cycle 1 - Day 18

1090.0
ng/mL (Geometric Mean)
Full Range: 1090.0 to 1100.0

Cycle 1 - Day 3

861.0
ng/mL (Geometric Mean)
Full Range: 762.0 to 1090.0

Cycle 2 - Day 18

849.0
ng/mL (Geometric Mean)
Full Range: 849.0 to 849.0

Cohort 5 - ALM201

Cycle 1 - Day 1

1990.0
ng/mL (Geometric Mean)
Full Range: 1730.0 to 2190.0

Cycle 1 - Day 18

1350.0
ng/mL (Geometric Mean)
Full Range: 1240.0 to 1420.0

Cycle 1 - Day 3

1490.0
ng/mL (Geometric Mean)
Full Range: 1390.0 to 1660.0

Cycle 2 - Day 18

1870.0
ng/mL (Geometric Mean)
Full Range: 1870.0 to 1870.0

Cohort 6 - ALM201

Cycle 1 - Day 1

1490.0
ng/mL (Geometric Mean)
Full Range: 890.0 to 2690.0

Cycle 1 - Day 18

1670.0
ng/mL (Geometric Mean)
Full Range: 1230.0 to 2880.0

Cycle 1 - Day 3

1620.0
ng/mL (Geometric Mean)
Full Range: 1160.0 to 3100.0

Cycle 2 - Day 18

1890.0
ng/mL (Geometric Mean)
Full Range: 1280.0 to 2790.0

Cycle 4 - Day 18

1680.0
ng/mL (Geometric Mean)
Full Range: 1100.0 to 2580.0

Cohort 7 - ALM201

Cycle 1 - Day 1

2550.0
ng/mL (Geometric Mean)
Full Range: 2100.0 to 3650.0

Cycle 1 - Day 18

2880.0
ng/mL (Geometric Mean)
Full Range: 2420.0 to 3450.0

Cycle 1 - Day 3

2690.0
ng/mL (Geometric Mean)
Full Range: 2300.0 to 3260.0

Cycle 2 - Day 18

2780.0
ng/mL (Geometric Mean)
Full Range: 2110.0 to 4310.0

Cycle 4 - Day 18

2140.0
ng/mL (Geometric Mean)
Full Range: 2140.0 to 2140.0

Cycle 6 - Day 18

6830.0
ng/mL (Geometric Mean)
Full Range: 6830.0 to 6830.0

Cohort 8 - ALM201

Cycle 1 - Day 1

1810.0
ng/mL (Geometric Mean)
Full Range: 465.0 to 4600.0

Cycle 1 - Day 18

2330.0
ng/mL (Geometric Mean)
Full Range: 2140.0 to 2530.0

Cycle 1 - Day 3

2750.0
ng/mL (Geometric Mean)
Full Range: 1450.0 to 4280.0

Cycle 2 - Day 18

1790.0
ng/mL (Geometric Mean)
Full Range: 1790.0 to 1790.0

Total

20
Participants

Age, Categorical

Race (NIH/OMB)

Sex: Female, Male

Overall Study

Cohort 1 - ALM201

Cohort 2 - ALM201

Cohort 3 - ALM201

Cohort 4 - ALM201

Cohort 5 - ALM201

Cohort 6 - ALM201

Cohort 7 - ALM201

Cohort 8 - ALM201

Drop/Withdrawal Reasons

Cohort 5 - ALM201

Cohort 1 - ALM201

Cohort 2 - ALM201

Cohort 3 - ALM201

Cohort 4 - ALM201

Cohort 6 - ALM201

Cohort 7 - ALM201

Cohort 8 - ALM201