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Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

ConditionAdvanced Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioAtla, Inc.

About this trial

The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma

Age ≥ 18 years

Adequate renal function

Adequate liver function

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • BA3182

    Drug

    Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM

Treatment groups

168 Participants
are divided into 1 treatment group
Group A: BA3182Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Assess dose limiting toxicity as defined in the protocol

Phase 1 Part 1: Safety Profile of BA3182

Time frame
Up to 24 months
2

Part 1: Assess maximum tolerated dose as defined in the protocol

Phase 1 Part 1: Safety Profile of BA3182

Time frame
Up to 24 months
3

Part 2: Confirmed overall response rate (ORR) per RECIST v1.1

Phase 1 Part 2: Antitumor activity of BA3182

Time frame
Up to 24 months

Secondary outcomes

1

Confirmed overall response rate (ORR) per RECIST v1.1

Phase 1 Part 1: Antitumor activity of BA3182

Time frame
Up to 24 months
2

Confirmed best overall response best overall response (BOR)

Phase 1: Antitumor activity of BA3182

Time frame
Up to 24 months
3

Confirmed duration of response (DOR)

Phase 1: Antitumor activity of BA3182

Time frame
Up to 24 months
4

Confirmed progression-free survival (PFS)

Phase 1: Antitumor activity of BA3182

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioAtla, Inc.

Lead sponsor

Source ClinicalTrials.gov
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