A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia

NCT07286032 | Recruiting Phase 3 FDA Drug

• 1 other identifier: SHR8735-303
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

Brief Summary

The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.

Conditions

Patients With Chemotherapy-Induced Thrombocytopenia

Outcome Measures

Primary Outcomes (6)

• Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months.

  around 6 months.

• Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months

  around 6 months

• Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months

  around 6 months

• Part B:A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years

  around 3 years

• Part B:No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of investigational product treatment until Cycle 2 Day 21, around 3 years.

  around 3 years.

• Part B:Complete two consecutive on-study chemotherapy cycles (Cycle 1 and Cycle 2) without thrombocytopenia-induced modification of any myelosuppressive agent, around 3 years;

  around 3 years;

Secondary Outcomes (5)

• Proportion of participants achieving platelet count ≥100×109/L without the use of rescue therapy within 14 days after initiating the investigational product treatment,around 3 years;

  around 3 years;

• platelet count nadir from Cycle 1 Day 1 until Cycle 2 Day 21, around 3 years;

  around 3 years;

• Proportion of participants free from serious bleeding events, during the treatment period from the initiation of IP treatment until C2D21, around 3 years;

  around 3 years;

• Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until Cycle 2 Day 21, around 3 years.

  around 3 years.

• Number of Adverse Events/Serious Adverse Events, safety lab parameters, vital signs, etc within study period, around 3 years.

  around 3 years.

Study Arms (2)

Part A: Hetrombopag Olamine

EXPERIMENTAL

Drug: Hetrombopag Olamine

Part B：Hetrombopag Olamine vs Hetrombopag Olamine Placebo

EXPERIMENTAL

Drug: Hetrombopag Olamine ；Hetrombopag Olamine Placebo

Interventions

Hetrombopag Olamine DRUG

For Part A, all participants would receive hetrombopag treatment.

Part A: Hetrombopag Olamine

Hetrombopag Olamine ；Hetrombopag Olamine Placebo DRUG

For Part B，participants would be randomized to receive hetrombopag treatment or matching placebo, respectively。

Part B：Hetrombopag Olamine vs Hetrombopag Olamine Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female gender, age ≥18 years at screening.
• Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma \[NSCLC\], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
• Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
• Life expectancy ≥6 months.
• Signed ICF for voluntary participation in the study and good compliance.

You may not qualify if:

• Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
• Hematologic malignancies.
• Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months prior to Study Day 1.
• Untreated brain metastases; or with leptomeningeal metastasis.
• Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
• Severe cardiovascular disorders or interventions within 6 months
• Have arterial/venous thrombosis within 6 months
• Known bleeding disorders, platelet dysfunction
• Severe haemorrhage during screening
• Acute or uncontrolled hepatitis B\&C infection
• Human immunodeficiency virus (HIV) infection.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (7)

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90254, United States

NOT YET RECRUITING

AdventHealth Hematology and Oncology Denver Cypress Hematology and Oncology

Denver, Colorado, 80210, United States

NOT YET RECRUITING

Oncology & Hematology Associates of West Broward

Coral Springs, Florida, 33065, United States

NOT YET RECRUITING

Mid-Florida Hematology & Oncology Centers, P.A.

Orange City, Florida, 32763, United States

RECRUITING

Springfield Clinic

Springfield, Illinois, 62702, United States

NOT YET RECRUITING

Morristown Medical Center

Morristown, New Jersey, 07039, United States

NOT YET RECRUITING

New York Cancer and Blood Specialists One Oncology

Shirley, New York, 11967, United States

NOT YET RECRUITING

Central Study Contacts

Junye Xiong

CONTACT

0518-82342973; junye.xiong@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 16, 2025
• Study Start: April 16, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2025-12

Locations

US (7)