CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 53 enrolled
Drug / intervention
HBM4003 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05167071
NCT05167071Phase 1Active
CompareCT.gov

An Open-Label, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 in Combination With Toripalimab/ Tislelizumab in Patients With Advanced NEN and Other Solid Tumors

Harbour BioMed (Guangzhou) Co. Ltd.·interventional·Posted Dec 22, 2021·Updated Apr 27, 2025

In Brief

A Phase 1 clinical trial evaluating HBM4003, Toripalimab, and 1 other intervention for Solid Tumors and 2 related conditions. Active but no longer recruiting, targeting 53 participants across 1 site.

Detailed Summary

To select RP2D/MTD of HBM4003 in combination with Toripalimab in dose confirmation part(Part 1) and use the RP2D in dose expansion part (Part 2) to evaluate the safety, tolerability, PK/PD and preliminary efficacy of in patients with advanced NEN and other solid tumors

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors, Neuroendocrine Tumors, CRC
CountriesChina
Collaborators--

Timeline

Phase 1ActiveOverdue
20222023202420252026
First PostedDec 22, 2021
Enrollment StartDec 28, 2021
Primary CompletionSep 30, 2025
Study CompletionJun 30, 2026
TodayJul 1, 2026
Enrollment to primary: 3.8 yearsPosted 4.5 years ago

Interventions

HBM4003drug

Subjects will be treated with HBM4003 on Day 1 during each 21-day cycle.

Toripalimabdrug

Subjects will be treated with Toripalimab on Day 1 during each 21-day cycle.

Tislelizumabdrug

Subjects will be treated with Tislelizumab on Day 1 during each 21-day cycle.