Trial intelligence / Profile preview

GQ1010 in Advanced Solid Tumors

NCT06464055Phase 2

Key facts

Status: Recruiting
Start: May 2024
Primary completion: May 2028
Countries: 1
Sponsor: GeneQuantum Healthcare
Modality: Small Molecules, Antibody-Drug Conjugates (ADCs), Engineered Antibody Formats

Drugs: BHV-1510
Conditions: malignant solid tumorgastric adenocarcinomagastroesophageal junction cancertriple negative breast cancer (TNBC)Hormone-Receptor-Positive Breast Cancer

Overview

Phase 2, open-label trial of BHV-1510 in malignant solid tumor, gastric adenocarcinoma, gastroesophageal junction cancer and 10 more (5 arms), sponsored by GeneQuantum Healthcare. Primary endpoints: Incidence and Severity of Adverse Events, Dose Limiting Toxicities and 3 more. Started May 2024; status: recruiting.

Design

5 arms

Study design: Non-randomizedOpen-label

Dose Escalation
GQ1010 Dose Escalation via BOIN design
Dose Expansion 1
GQ1010 at RDE
Dose Expansion 2
GQ1010 at RDE
Dose Expansion 3
GQ1010 at RDE
Phase II
GQ1010 at RP2D in 5 cohorts

Endpoints

Primary

Incidence and Severity of Adverse EventsScreening up to study completion (avg 1 year)
Dose Limiting Toxicities21 days or 28 days
Maximal Tolerance DoseAfter DLT observation period
Recommended Phase II DoseAfter cohort completion (avg 6 months)
Objective Response RateScreening up to study completion (avg 1 year)

Secondary

Maximum ConcentrationScreening up to study completion (avg 1 year)
Time of Peak Plasma ConcentrationScreening up to study completion (avg 1 year)
Area Under the Plasma Concentration Time CurveScreening up to study completion (avg 1 year)
Terminal Half-LifeScreening up to study completion (avg 1 year)
Objective Response RateScreening up to study completion (avg 1 year)
Duration of ResponseScreening up to study completion (avg 1 year)
Disease Control RateScreening up to study completion (avg 1 year)
Progression-Free SurvivalScreening up to study completion (avg 1 year)

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