Advanced AdenocarcinomaPhase 1NCT05808634
Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.
A Phase 1 study testing BA3182 in people with Advanced Adenocarcinoma, run by BioAtla, Inc. at 9 sites in United States.
Trial summary
The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Adenocarcinoma
- What is being tested?
- BA3182
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 Jul 2023to 15 Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma
- Age ≥ 18 years
- Adequate renal function
- Adequate liver function
- Adequate hematological function
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Who cannot join
- Patients must not have clinically significant cardiac disease.
- Patients must not have known non-controlled CNS metastasis.
- Patients must not have active autoimmune disease or a documented history of autoimmune disease.
- 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 incomplete recovery from the effects of major surgery or significant traumatic injury before the first dose of study treatment.
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Clinical Research Office, 312-695-1301, cancer@northwestern.edu
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Omer Qazi, 312-413-1069, omerqazi@uic.edu
- Recruiting
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219
Abby Reed, 513-585-0844, abby.reed@thechristhospital.com
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Principal Investigator, 216-844-3951, Madison.Conces@UHHospitals.org
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Clarice Zuccaro, 313-576-9375, zuccaroc@karmanos.org
- Recruiting
UC Irvine
Irvine, California, 92697
Chao Family Comprehensive Cancer Center, 877-827-8839, ucstudy@hs.uci.edu
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Lorraine Martinez Seng, 323-865-3000, Lorraine.Martinez@med.usc.edu
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06511
Ingrid Palma, 203-833-1034, ingrid.palma@yale.edu
- Recruiting
Fred Hutch Cancer Center
Seattle, Washington, 98109
Phase 1 Clinical Trials, 206-606-7551, phase1clinicaltrial@fredhutch.org
About this study
Official title: An Open-label, Multicenter, Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Efficacy of BA3182, a Bispecific Epithelial Cell Adhesion Molecule (EpCAM)/CD3 Antibody, in Patients With Advanced Adenocarcinoma
The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma
Read the detailed description
This is a multi-center, open-label, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3182 in patients with advanced adenocarcinoma.
- Conditions
- Advanced Adenocarcinoma
- Being tested
- BA3182
- Keywords
- Advanced, Metastatic, Cancer
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BA3182Drug
Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM
| Study group | Role | What they receive |
|---|---|---|
| BA3182 | Experimental | All Patients will receive BA3182 Receives: Drug: BA3182 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Assess dose limiting toxicity as defined in the protocol
Phase 1 Part 1: Safety Profile of BA3182
Measured: Up to 24 months
Part 1: Assess maximum tolerated dose as defined in the protocol
Phase 1 Part 1: Safety Profile of BA3182
Measured: Up to 24 months
Part 2: Confirmed overall response rate (ORR) per RECIST v1.1
Phase 1 Part 2: Antitumor activity of BA3182
Measured: Up to 24 months
Secondary outcomes (12)
Confirmed overall response rate (ORR) per RECIST v1.1
Phase 1 Part 1: Antitumor activity of BA3182
Measured: Up to 24 months
Confirmed best overall response best overall response (BOR)
Phase 1: Antitumor activity of BA3182
Measured: Up to 24 months
Confirmed duration of response (DOR)
Phase 1: Antitumor activity of BA3182
Measured: Up to 24 months
Confirmed progression-free survival (PFS)
Phase 1: Antitumor activity of BA3182
Measured: Up to 24 months
Confirmed disease control rate (DCR)
Phase 1: Antitumor activity of BA3182
Measured: Up to 24 months
Confirmed time to response (TTR)
Phase 1: Antitumor activity of BA3182
Measured: Up to 24 months
Confirmed overall survival (OS)
Phase 1: Antitumor activity of BA3182
Measured: Up to 24 months
Confirmed percent change from baseline in target lesion sum of diameters.
Phase 1: Antitumor activity of BA3182
Measured: Up to 24 months
Area under the plasma concentration versus time curve (AUC)
Phase 1: Pharmacokinetics of BA3182
Measured: Up to 24 months
Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics
Phase 1: Pharmacokinetics of BA3182
Measured: Up to 24 months
Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity
Phase 1: Immunogenicity of BA3182
Measured: Up to 24 months
Incidence of neutralizing antibodies (nAbs) to BA3182.
Phase 1: Immunogenicity of BA3182
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start14 Jul 2023
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioAtla, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808634
- Sponsor's protocol ID
- BA3182-001
- Status last verified
- Sep 2025
- First submitted
- 17 Mar 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Efficacy of BA3182, a Bispecific Epithelial Cell Adhesion Molecule (EpCAM)/CD3 Antibody, in Patients With Advanced Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05808634
- Acronym / sponsor ID
- BA3182-001
- Conditions
- Advanced Adenocarcinoma
- Keywords
- Advanced, Metastatic, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- BioAtla, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma
Detailed description
This is a multi-center, open-label, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3182 in patients with advanced adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BA3182 | Experimental | Drug: BA3182All Patients will receive BA3182 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma
- Age ≥ 18 years
- Adequate renal function
- Adequate liver function
- Adequate hematological function
Key exclusion criteria (7 listed)
- Patients must not have clinically significant cardiac disease.
- Patients must not have known non-controlled CNS metastasis.
- Patients must not have active autoimmune disease or a documented history of autoimmune disease.
- 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 incomplete recovery from the effects of major surgery or significant traumatic injury before the first dose of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BA3182Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM | Drug | BA3182 |
Primary outcome
Part 1: Assess dose limiting toxicity as defined in the protocol
Time frame: Up to 24 months
Phase 1 Part 1: Safety Profile of BA3182
Part 1: Assess maximum tolerated dose as defined in the protocol
Time frame: Up to 24 months
Phase 1 Part 1: Safety Profile of BA3182
Part 2: Confirmed overall response rate (ORR) per RECIST v1.1
Time frame: Up to 24 months
Phase 1 Part 2: Antitumor activity of BA3182
12 secondary outcomes
Confirmed overall response rate (ORR) per RECIST v1.1
Time frame: Up to 24 months
Confirmed best overall response best overall response (BOR)
Time frame: Up to 24 months
Confirmed duration of response (DOR)
Time frame: Up to 24 months
Confirmed progression-free survival (PFS)
Time frame: Up to 24 months
Confirmed disease control rate (DCR)
Time frame: Up to 24 months
Confirmed time to response (TTR)
Time frame: Up to 24 months
Confirmed overall survival (OS)
Time frame: Up to 24 months
Confirmed percent change from baseline in target lesion sum of diameters.
Time frame: Up to 24 months
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 24 months
Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics
Time frame: Up to 24 months
Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity
Time frame: Up to 24 months
Incidence of neutralizing antibodies (nAbs) to BA3182.
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BA3182 in people with Advanced Adenocarcinoma, run by BioAtla, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BioAtla Medical Affairs (858-558-0708 ext. 3333, medicalaffairs@bioatla.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Assess dose limiting toxicity as defined in the protocol (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.