A Phase Ib/II Clinical Study Evaluating HMPL-453 Tartrate as Monotherapy and in Combination With Chemotherapy or Toripalimab in Advanced Solid Tumors

NCT05173142 | Completed Phase 1

• 1 other identifier: 2021-453-00CH1
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase Ib/II Clinical Study Evaluating HMPL-453 Tartrate as Monotherapy and in Combination with Chemotherapy or Toripalimab in Advanced Solid Tumors

Conditions

Solid Tumor

Keywords

HMPL-453, FGFR, PD-1,IHCC, ICC, gastric cancer

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability(Incidence and severity of adverse events (AEs))

  DLT, TEAEs and SAEs

  6 months after the last patient enrolled

• Preliminary efficacy/Objective response rate (ORR)

  Objective response rate (ORR) in patients with the selected tumors along with certain FGFR gene alterations

  up to 2 years

Secondary Outcomes (5)

• Efficacy/Progression-free survival (PFS)

  up to 2 years

• disease control rate (DCR)

  up to 2 years

• time to response (TTR)

  up to 2 years

• duration of response (DoR）

  up to 2 years

• overall survival (OS)

  up to 2 years

Study Arms (2)

dose escalation phase of HMPL-453 monotherapy or combination therapy

EXPERIMENTAL

HMPL-453 monotherapy or combination therapy

Drug: HMPL-453; Drug: gemcitabine and cisplatin; Drug: toripalimab

indication specific dose expansion phase of HMPL-453 monotherapy or combination therapy

EXPERIMENTAL

HMPL-453 monotherapy or combination chemotherapy, in patients with IHCC, G/GEJ, UC, and solid tumors harboring specific FGFR gene alterations

Drug: HMPL-453; Drug: gemcitabine and cisplatin; Drug: toripalimab; Drug: Docetaxel

Interventions

HMPL-453 DRUG

HMPL-453 administered orally.

dose escalation phase of HMPL-453 monotherapy or combination therapy; indication specific dose expansion phase of HMPL-453 monotherapy or combination therapy

gemcitabine and cisplatin DRUG

Gemcitabine and Cisplatin administered intravenously.

dose escalation phase of HMPL-453 monotherapy or combination therapy; indication specific dose expansion phase of HMPL-453 monotherapy or combination therapy

toripalimab DRUG

Toripalimab administered intravenously.

dose escalation phase of HMPL-453 monotherapy or combination therapy; indication specific dose expansion phase of HMPL-453 monotherapy or combination therapy

Docetaxel DRUG

Docetaxel administered intravenously.

indication specific dose expansion phase of HMPL-453 monotherapy or combination therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dose escalation phase: patients with histologically or cytologically confirmed locally advanced or metastatic solid tumor who progressed on or are intolerant of standard therapy;
• Dose expansion phase: patients with UC, GC/GEJ, or IHCC harboring specific FGFR gene alterations;
• Age 18 to 75 years;
• Those who are able to give written informed consent, and able to comply with protocol-specified visits and related procedures;
• Ability to swallow study drug;
• ECOG PS of 0 or 1;
• Measurable lesion according to RECIST v1.1, refer to the protocol;
• Adequate organ and bone marrow function;
• Life expectancy ≥ 12 weeks;
• Female patients or male patients with partners of childbearing potential must take effective contraceptive measures per the protocol.

You may not qualify if:

• Patients who previously received selective FGFR targeting therapy;
• Concurrent participation in another interventional clinical study, excluding those in the follow-up period and have not recently received investigational intervention;
• Current or previous history of central nervous system (CNS) metastases；
• Current or previous history of retinal detachment；
• Known history of primary immunodeficiency;
• Female patients who are pregnant or lactating；
• Patients who in the opinion of the investigator may be unsuitable for participating in the study;
• Patients with acute or chronic active hepatitis B or C infection;
• Known human immunodeficiency virus (HIV) infection and syphilis infection；
• Clinically significant cardiovascular disease such as congestive heart failure or arrhythmia；
• Uncontrolled hypertension despite optimal medical management；
• Received live vaccine within 30 days before the first dose of study drug(s);
• Those who have undergone major surgical procedures (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to the first study treatment or who are expected to be in need of major surgery; those with unhealed wounds, ulcers or fractures.

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gemcitabine; Cisplatin; toripalimab; Docetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: December 29, 2021
• Study Start: January 22, 2022
• Primary Completion: July 17, 2025
• Study Completion: January 17, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CN (1)