A Phase 1/2 interventional study of CAB-AXL-ADC and PD-1 inhibitor in Undifferentiated Pleomorphic Sarcoma and Myxofibrosarcoma, sponsored by BioAtla, Inc.. Completed at 40 sites in 3 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by BioAtla, Inc. · Phase 1/2, Interventional, and Treatment
The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.
This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of mecbotamab vedotin (BA3011), a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors.
Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (enrollment complete as of Jan 2024).
Phase 2 will consist of two parts. Part 1 is designed to evaluate mecbotamab vedotin alone and with nivolumab in patients with various types of advanced sarcomas (enrollment complete as of Jan 2024). Part 2 will evaluate the safety and efficacy of mecbotamab vedotin in patients with undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).
91 studies on the registry are indexed under Histiocytoma, Malignant Fibrous; 15 are open to participants now.
This study's enrollment of 245 is above the median of 64 across 81 interventional studies indexed under Histiocytoma, Malignant Fibrous.
Browse Histiocytoma, Malignant Fibrous studies →BioAtla, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Phase 2: BA3011 in combination with PD-1 inhibitor.
Biological: CAB-AXL-ADC · Biological: PD-1 inhibitor
Conditionally active biologic anti-AXL antibody drug conjugate
PD-1 inhibitor
This study also gives Nivolumab. No intervention listed here names it: that was found by reading the record.
Phase 1: Safety Profile
Assess dose limiting toxicity as defined in the protocol
Time frame: Up to 24 months
Phase 1: Safety Profile
Assess maximum tolerated dose as defined in the protocol
Time frame: Up to 24 months
Phase 1 and 2: Safety Profile
Frequency and severity of AEs and/or SAEs, and changes from baseline in laboratory parameters and vital signs
Time frame: Up to 24 months
Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
Time frame: Up to 24 months
Phase 1: Pharmacokinetics
Plasma concentrations of ADC, total antibody and MMAE
Time frame: Up to 24 months
Phase 1: Pharmacokinetics
Peak Plasma Concentration (Cmax)
Time frame: Up to 24 months
Phase 1: Pharmacokinetics
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 24 months
Phase 1: Overall response rate (ORR)
Proportion of patients who achieve a confirmed CR or PR
Time frame: Up to 24 months
Phase 1: Immunogenicity
The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)
Time frame: Up to 24 months
Phase 1 and 2: Duration of response (DOR)
Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first
Time frame: Up to 24 months
Phase 1 and 2: Progression-free survival (PFS)
Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first
Time frame: Up to 24 months
Phase 1 and 2: Best overall response (BOR)
All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Time frame: Up to 24 months
Phase 1 and 2: Disease control rate (DCR)
Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks
Time frame: Up to 24 months
Phase 1 and 2: Time to response (TTR)
Time from the first dose of investigational product until the first documentation of OR
Time frame: Up to 24 months
Phase 1 and 2: Overall survival (OS)
Time from the first dose of BA3011 treatment until death due to any cause
Time frame: Up to 24 months
Phase 1 and 2: Tumor size
Percent change from baseline in tumor size
Time frame: Up to 24 months
Plan to share: Undecided
Ran from Feb 2018 to primary completion in Jan 2025, 82 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Histiocytoma, Malignant Fibrous →
BioAtla, Inc.