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Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma

ConditionsGastric CancerGastric AdenocarcinomaGastric (Stomach) CancerGastroesophageal AdenocarcinomaGastroesophageal Cancer (GC)Gastroesophageal Junction (GEJ) AdenocarcinomaGastroesophageal Junction (GEJ) CancerGastrointestinal Cancer MetastaticGastrointestinal AdenocarcinomaGastrointestinal CancersColorectal (Colon or Rectal) CancerPancreatic CancerCDH17-positive Advanced Solid TumorsAdvanced Gastric Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBigHat Biosciences, Inc.

About this trial

This study is looking at how safe BHB810 is in adults with gastric and gastroesophageal adenocarcinoma (GEJ). The purpose of this study is also to look at: how well the study drug works, how the study drug moves into, through, and out of the body, and how your body reacts to the study drug. Participants will get an IV infusion of BHB810 every 2 weeks while on study treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.

Histologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on, was nonresponsive to, or for which no standard or available curative therapy exists.

Participants in Phase 1 Backfill Cohorts & Phase 2 must be CDH17-positive by central testing.

Other gastrointestinal (GI) tumor types may be enrolled in Backfill Cohorts and Phase 2.

Disqualifiers

Chemotherapy or targeted therapy withing 4 weeks or 5-halflives (whichever is shorter)

Monoclonal antibody-based therapy (including ADCs) within 4 weeks

Immune checkpoint inhibitors within 4 weeks

Wide-field radiation therapy (>30% marrow-bearing bones) within 4 weeks or < 2 weeks of focal palliative radiation to nontarget lesions

Trial design

Design model

Sequential

Treatments tested in this trial

  • BHB810

    Drug

    Every 2 weeks IV administration

Treatment groups

164 Participants
are divided into 3 treatment groups
Group A: Dose Escalation and Backfill CohortsExperimental treatment 1 intervention
Group B: Recommended Phase 2 Dose Level 1 (RP2D1)Experimental treatment 1 intervention
Group C: Recommended Phase 2 Dose Level 2 (RP2D2)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs) per Common Terminology Criteria for Adverse Events v6.0 (CTCAE v6.0)

Investigate the safety and tolerability of BHB810 by evaluation of AEs, SAEs, DLTs, and clinically significant changes safety assessments, like lab tests, vital signs, and other safety assessments Phase 1 (Dose Escalation \& Backfill Cohorts) and Phase 2 (Dose Optimization) DLTs apply to Phase 1 Dose Escalation Cohorts only.

Time frame
Cycle 1 Day 1 through 30 days after the last dose, an average of 6 months
2

Incidence of participants who have a dose modification of BHB810 due to toxicity

Investigate the safety and tolerability of BHB810 by assessment of dose modifications due to toxicity Phase 1 (Dose Escalation \& Backfill Cohorts)

Time frame
Cycle 1 Day 1 through 30 days after the last dose, an average of 6 months
3

Overall Response Rate (ORR)

Identify the recommended Phase 2 dose (RP2D) by comparing 2 doses of BHB810 by evaluating the ORR of participants according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Phase 2 (Dose Optimization)

Time frame
Screening through End of Treatment, an average of 6 months

Secondary outcomes

1

Clinical Benefit Rate (CBR)

Investigate preliminary antitumor activity of BHB810 as assessed by radiological response per RECIST v1.1 Number of participants who achieve stable disease (SD) for at least 6 months, or PR or CR for any duration Phase 1 (Dose Escalation \& Backfill Cohorts)

Time frame
Screening through End of Treatment, an average of 6 months
2

Duration of Response (DOR)

Investigate preliminary antitumor activity of BHB810 as assessed by radiological response per RECIST v1.1 Time from PR or CR to disease progression Phase 1 (Dose Escalation \& Backfill Cohorts) Phase 2 (Dose Optimization)

Time frame
Screening through End of Treatment or last scan, an average of 6 months
3

Progression Free Survival (PFS)

Investigate preliminary antitumor activity of BHB810 as assessed by radiological response per RECIST v1.1 Time from first dose to first documented date of progression per RECIST v1.1 Phase 1 (Dose Escalation \& Backfill Cohorts) Phase 2 (Dose Optimization)

Time frame
Screening through End of Treatment, an average of 6 months
4

Overall Survival (OS)

Investigate preliminary antitumor activity of BHB810 Time from first dose to death from any cause Phase 1 (Dose Escalation \& Backfill Cohorts) Phase 2 (Dose Optimization)

Time frame
Screening through End of Study, an average of 10 months

Other outcomes

Sponsors and contacts

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

BigHat Biosciences, Inc.

Lead sponsor

Source ClinicalTrials.gov
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