A Study of Hansoh (HS)-10502 in Patients With Advanced Solid Tumors

NCT05740956 | Recruiting Phase 1 DMC

• 1 other identifier: HS-10502-101
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

HS-10502 is a Poly(ADP-ribose) polymerase 1 (PARP1)-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 in subjects with homologous recombination repair (HRR) gene mutant or homologous recombination deficiency (HRD) positive advanced solid tumors.

Conditions

Ovarian Cancer; Breast Cancer; Pancreatic Cancer; Prostatic Cancer; Colorectal Cancer

Keywords

Poly(ADP-ribose) polymerase-1 inhibitor; HS-10502; Ovarian Cancer; Breast Cancer; Prostate Cancer, Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD) of HS-10502（Stage 1）

  MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a Dose-limiting toxicity (DLT)

  Cycle 1 (28 days)

• Maximum applicable dose (MAD) of HS-10502（Stage 1）

  MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the pharmacokinetics-pharmacodynamics (PK-PD) model, it suggested that the optimal target concentration of safety and efficacy has been explored

  Cycle 1 (28 days)

• Efficacy of HS-10502: Objective response rate (ORR)（Stage 2）

  ORR is defined as the proportion of participants with Best Overall Response (BOR) of confirmed CR or confirmed PR per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and PCWG3 (for prostate cancer only)

  From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years

Secondary Outcomes (18)

• [Stage 1 and Stage 2] Incidence and severity of treatment-emergent adverse events

  From Cycle 1 Day 1 (C1D1) until 28 days after the final dose. A cycle is 28 days

• [Stage 1 and Stage 2] PK parameters: The maximum observed concentration (Cmax) of HS-10502

  Cycle 1 Day 1 (each cycle is 28 days)

• [Stage 1 and Stage 2] PK parameters: time to Cmax (Tmax) of HS-10502

  Cycle 1 Day 1 (each cycle is 28 days)

• [Stage 1 and Stage 2] PK parameters: area under the concentration-time curve from time 0 to time t of last measurable concentration (AUC0-t) of HS-10502

  Cycle 1 Day 1 (each cycle is 28 days)

• [Stage 1 and Stage 2] PK parameters: Maximum plasma concentration at steady state (Css, max) of HS-10502

  Cycle 2 Day 1 (each cycle is 28 days)

Study Arms (1)

HS-10502

EXPERIMENTAL

HS-10502 Tablets，PO，QD

Drug: HS-10502

Interventions

HS-10502 DRUG

HS-10502 will be administered once per day on a continuous dosing schedule starting on Cycle 1 Day 1 (C1D1) in a 28-day treatment cycle.

HS-10502

Eligibility Criteria

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

You may qualify if:

• Males or females aged 18 - 75 years (inclusive).
• Having at least one target lesion per the RECIST v1.1.
• For the phase Ia Cohort A: advanced solid tumor carrying HRR gene mutation with failure or intolerance or not available to the currently available Standard of care (SoC).
• For the phase Ib study:
• Cohort B: patients with HRD positive recurrent ovarian cancer with failure or intolerance or not available to SoC Cohort C: patients with HRR gene mutation advanced Human epidermal growth factor receptor 2 (HER2)-negative breast cancer with failure or intolerance or not available to SoC Cohort D: patients with HRR gene mutation advanced pancreatic cancer with failure or intolerance or not available to SoC Cohort E: patients with HRR gene mutation mCRPC with failure or intolerance or not available to SoC Cohort F: patients with HRR gene mutation colorectal cancer with failure or intolerance or not available to SoC Cohort G: patients with other HRR gene mutation or HRD positive advanced solid tumors with failure or intolerance or not available to SoC
• Eastern cooperative oncology group (ECOG) performance status was 0-1.
• Minimum life expectancy \> 12 weeks.
• Females should be using adequate contraceptive measures and should not be breastfeeding Males should be using adequate contraceptive measures.
• Have signed Informed Consent Form.

You may not qualify if:

• Received or are receiving the following treatments:
• Previous or current treatment with two or more Poly(ADP-ribose) polymerase (PARP) inhibitors.
• Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.
• Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment; Nitrosourea or Mitomycin C within 6 weeks prior to the first dose of study treatment.
• Local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment.
• Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
• Major surgery within 4 weeks prior to the first dose of study treatment.
• Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
• History of other primary malignancies.
• Known and untreated, or active central nervous system metastases.
• Inadequate bone marrow reserve or hepatic and renal functions.
• Myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML), or with features suggestive of MDS or AML.
• Severe, uncontrolled or active cardiovascular disorders.
• Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to the first dose of study treatment; glycosylated hemoglobin ≥ 7.5%.
• Serious or poorly controlled hypertension.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Acedemy of Medical Sciences

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Pancreatic Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Lingying Wu, Medical PhD

CONTACT

13910865483; wulingying@csco.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: June 9, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

CN (1)