Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors

Summary

This is a non-randomized, open-label, dose-escalation, and dose-expansion Phase Ib/IIa study to evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of HCB101 administered in combination with standard or approved anticancer therapies in subjects with advanced solid tumors. The trial includes a Part-I (Phase Ib) of the dose-escalation phase and a Part-II (Phase IIa) of the dose-expansion phase.

Part-I: Dose-escalation phase (Phase Ib):

Part I uses a standard 3+3 dose-escalation design to characterize safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of HCB101 when administered in combination regimens. The study includes 14 planned cohorts (Cohorts 1-9, including sub-cohorts 3a-3d and 6a-6c).

Part-II: Dose-expansion phase (Phase IIa) Based on safety, tolerability, PK/PD, and emerging antitumor activity observed in Part-I (Phase Ib), selected dose levels, tumor types, and combination regimens will be further investigated in Part-II (Phase IIa).

Conditions

• Solid Cancer

Interventions

DRUG

HCB101

QW

DRUG

Trastuzumab

8 mg/kg IV loading dose on Day 1 of cycle 1, then 6 mg/kg IV every 21 days;

DRUG

Pertuzumab

840 mg IV on Day 1, cycled every 21 days;

DRUG

Oxaliplatin

130 mg/m2 IV on Day 1, cycled every 21 days

DRUG

Capecitabine

1000 mg/m2 PO BID on Days 1-14, Cycled every 21 days

DRUG

Ramucirumab

8 mg/kg IV on Days 1 and 15, Cycled every 28 days

DRUG

Paclitaxel

80 mg/m2 IV on Days 1, 8, and 15, Cycled every 28 days

DRUG

Bevacizumab

5 mg/kg IV on Day 1, Repeat every 2 weeks;

DRUG

Cetuximab

400 mg/m2 first infusion, followed by 250 mg/m2 IV weekly;

DRUG

Irinotecan

180 mg/m2 IV over 30-90 minutes on Day 1 every 2 weeks

DRUG

Leucovorin

400 mg/m2 IV on Day 1 every 2 weeks

DRUG

5-FU

400 mg/ m2 IV bolus on Day 1, followed by 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks

DRUG

Toripalimab

240 mg/kg IV on Day 1 Cycled every 21 days

DRUG

Albumin-bound paclitaxel

125 mg/m2 IV on day 1 and Day 8 Cycled every 21 days

DRUG

Pembrolizumab

200 mg IV day 1; given every 21 days

DRUG

Carboplatin (AUC 5)

AUC=5, IV on D1, Q3W for 4\~6 cycles

DRUG

Etoposide

100mg/m2, IV on D1, 2, 3, Q3W for 4\~6 cycles

DRUG

Atezolizumab

1200 mg IV on D1, Q3W

DRUG

Trastuzumab deruxtecan

5.4 mg/kg IV on D1, Q3W

Sponsors & Collaborators

• FBD Biologics Limited

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-13

Primary Completion

2028-01-01

Completion

2029-01-01

FDA Drug

Yes

Countries

• China

Study Locations