Phase 2 CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma

• Sponsor: BioAtla, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03425279
• Collaborator: (none)
• Enrollment: 120
• Locations: 34
• Arms: 2
• Anticipated Duration (Months): 81.5
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor; Non Small Cell Lung Cancer; Melanoma; Sarcoma; Sarcoma, Ewing; Osteosarcoma; Leiomyosarcoma; Synovial Sarcoma; Liposarcoma; Soft Tissue Sarcoma; Bone Sarcoma; Refractory Sarcoma	Biological: CAB-AXL-ADC; Biological: PD-1 inhibitor	Phase 1/Phase 2

Detailed Description

This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3011, a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors in Phase 1 and BA3011 alone and in combination with a PD-1 inhibitor in Phase 2.

Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (still enrolling ACC patients only).

Phase 2 is targeted to begin in Q3 2020 and will include both adult and adolescents age 12 and over.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1/ 2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-AXL-ADC, Alone and in Combination With a PD-1 Inhibitor in Adult Patients With Advanced Solid Tumors (Phase 1) and Adult and Adolescent Patients With Advanced, Refractory Sarcoma (Phase 2)
• Actual Study Start Date: Feb 15, 2018
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BA3011 Phase 1: All patients will receive BA3011, CAB-AXL-ADC. Phase 2: All patients will receive either BA3011 alone or in combination with PD-1 inhibitor.	Biological: CAB-AXL-ADC; Conditionally active biologic anti-AXL antibody drug conjugate
Experimental: Combination Therapy Phase 2: BA3011 in combination with PD-1 inhibitor.	Biological: CAB-AXL-ADC; Conditionally active biologic anti-AXL antibody drug conjugate; Biological: PD-1 inhibitor; PD-1 inhibitor

Outcome Measures

Primary Outcome Measures

1. Phase 1: Safety Profile [Up to 24 months]

   Assess dose limiting toxicity as defined in the protocol

2. Phase 1: Safety Profile [Up to 24 months]

   Assess maximum tolerated dose as defined in the protocol

3. Phase 1 and 2: Safety Profile [Up to 24 months]

   Frequency and severity of AEs and/or SAEs

4. Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1 [Up to 24 months]

   Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1

Secondary Outcome Measures

1. Phase 1: Pharmacokinetics [Up to 24 months]

   Plasma concentrations of ADC, total antibody and MMAE

2. Phase 1: Pharmacokinetics [Up to 24 months]

   Peak Plasma Concentration (Cmax)

3. Phase 1: Pharmacokinetics [Up to 24 months]

   Area under the plasma concentration versus time curve (AUC)

4. Phase 1: Overall response rate (ORR) [Up to 24 months]

   Proportion of patients who achieve a confirmed CR or PR

5. Phase 1: Immunogenicity [Up to 24 months]

   The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)

6. Phase 1 and 2: Duration of response (DOR) [Up to 24 months]

   Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first

7. Phase 1 and 2: Progression-free survival (PFS) [Up to 24 months]

   Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first

8. Phase 1 and 2: Best overall response (OR) [Up to 24 months]

   All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy

9. Phase 1 and 2: Disease control rate (DCR) [Up to 24 months]

   Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks

10. Phase 1 and 2: Time to response (TTR) [Up to 24 months]

    Time from the first dose of investigational product until the first documentation of OR

11. Phase 1 and 2: Overall survival (OS) [Up to 24 months]

    Time from the first dose of BA3011 treatment until death due to any cause

12. Phase 1 and 2: Tumor size [Up to 24 months]

    Percent change from baseline in tumor size

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must have measurable disease.

• Age ≥ 12 years (Phase 2)

• Adequate renal function

• Adequate liver function

• Adequate hematological function

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Life expectancy of at least three months.

Exclusion Criteria:

• Patients must not have clinically significant cardiac disease.

• Patients must not have known non-controlled CNS metastasis.

• Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study.

• Patients must not have had major surgery within 4 weeks before first BA3011 administration.

• Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.

• Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.

• Patients must not be women who are pregnant or breast feeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Arizona Cancer Center	Tucson	Arizona	United States	85724
2	Children's Hospital Los Angeles	Los Angeles	California	United States	90027
3	USC Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
4	Tower Hematology Oncology Medical Group	Los Angeles	California	United States	90048
5	UCSF Medical Center - Cancer Immunotherapy Clinic (CIC)	San Francisco	California	United States	94158
6	University of Colorado	Aurora	Colorado	United States	80045
7	Sarah Cannon Research Institute at Health One	Denver	Colorado	United States	80218
8	Children's Research Institute	Washington	District of Columbia	United States	20010
9	Moffitt Cancer Center	Tampa	Florida	United States	33612
10	Northwestern University	Chicago	Illinois	United States	60611
11	Norton Cancer Institute	Louisville	Kentucky	United States	40202
12	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
13	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
14	Comprehensive Cancer Center of Nevada	Las Vegas	Nevada	United States	89169
15	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
16	Columbia University	New York	New York	United States	10032
17	Memorial Sloan Kettering	New York	New York	United States	10065
18	Duke Cancer Institute	Durham	North Carolina	United States	27710
19	Wake Forest Baptist Health	Winston-Salem	North Carolina	United States	27157
20	University Hospitals Seidman Cancer Center	Cleveland	Ohio	United States	44106
21	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
22	Oregon Health & Science University	Portland	Oregon	United States	97239
23	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
24	Tennessee Oncology	Nashville	Tennessee	United States	37203
25	Vanderbilt Ingram Cancer Center	Nashville	Tennessee	United States	37232
26	Mary Crowley Cancer Research	Dallas	Texas	United States	75230
27	MD Anderson Cancer Center	Houston	Texas	United States	77030
28	University of Utah - Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
29	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
30	Prince of Wales Hospital	Hong Kong		Hong Kong
31	Queen Mary Hospital	Hong Kong		Hong Kong
32	National Cheng Kung University Hospital	Tainan		Taiwan
33	Taipei Veterans General Hospital	Taipei		Taiwan
34	Chang Gung Memorial Hospital	Taoyuan		Taiwan

Sponsors and Collaborators

• BioAtla, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BioAtla, Inc.
• ClinicalTrials.gov Identifier: NCT03425279
• Other Study ID Numbers: BA3011-001
• First Posted: Feb 7, 2018
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by BioAtla, Inc.: late stage; stage 3; stage 4; cancer
• Additional relevant MeSH terms: Sarcoma; Osteosarcoma; Leiomyosarcoma; Liposarcoma; Sarcoma, Synovial; Sarcoma, Ewing; Neuroectodermal Tumors, Primitive, Peripheral; Immune Checkpoint Inhibitors

Study Results

No Results Posted as of Jul 13, 2022