A Phase I Study of HS-10386 in Participants With Advanced Solid Tumors

NCT05911464 | Recruiting Phase 1

• 1 other identifier: HS-10386-101
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of HS-10386 in participants with advanced solid tumors who have failed prior treatments.

Conditions

Advanced Solid Tumor

Keywords

Advanced Solid Tumors; Immuno-Oncology Therapy; Immunotherapy; Immune Checkpoint Inhibitor; PD-1; PD-L1

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD) or Maximum Applicable Dose (MAD) (Dose Escalation Phase)

  MTD is defined as the dose level immediately below that at which 2 or more patients exhibit dose limiting toxicity. MAD is defined as the maximum administered dose, when MTD is not reached.

  Up to 21 days from the first dose

• Objective Response Rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Dose Expansion Phase)

  ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression.

  Every 6 weeks for the duration of study participation; estimated to be 12 months.

Secondary Outcomes (13)

• Incidence and Severity of Adverse Events (AEs)

  From Informed consent until the end of the follow-up period which is defined as 28 days (+7 days) after study treatment is discontinued.

• Cmax of HS-10386

  Approximately 1 month.

• Tmax of HS-10386

  Approximately 1 month.

• λz of HS-10386

  Approximately 1 month.

• t1/2 of HS-10386

  Approximately 1 month.

Study Arms (1)

HS-10386

EXPERIMENTAL

Participants will receive HS-10386 once daily. The duration of each treatment cycle is 21 days.

Drug: HS-10386

Interventions

HS-10386 DRUG

Starting dose 10 mg, administered once daily. If tolerated, subsequent cohorts will test increasing doses of HS-10386, until a maximum tolerated dose (MTD) or maximum applicable dose (MAD) is defined

HS-10386

Eligibility Criteria

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

You may qualify if:

• Male or female, 18-75 years old.
• Histologically or cytologically documented, incurable or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable.
• At least one measurable lesion per RECIST v1.1.
• Willingness to provide fresh or archival tumor biopsy sample.
• An Eastern Cooperative Oncology Group (ECOG) performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
• Willingness to use adequate contraceptive measures throughout the study.
• Ability to comprehend and willingness to sign a written ICF for the study.

You may not qualify if:

• Treatment with any of the following:
• Previous or current treatment with systemic immunotherapy.
• Treatment with anticancer medications or investigational drugs within protocol-defined intervals prior to the first scheduled dose of HS-10386.
• Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except for alopecia.
• Known additional malignancy.
• History or risk of autoimmune disease.
• Known primary CNS malignancy or symptomatic CNS metastases. Patients with asymptomatic CNS metastases may be enrolled after consultation.
• Inadequate bone marrow reserve or organ function.
• Clinically significant cardiac disease.
• Any evidence of severe or uncontrolled systemic diseases
• Severe infections within 4 weeks prior to the first scheduled dose or symptoms of infection within 2 weeks prior to prior to the first scheduled dose.
• History of organ transplantation or any medical condition requiring the use of systemic immunosuppressive medications.
• Active HBV or HCV infection that requires treatment.
• Known history of HIV.
• Women who are breastfeeding or have a positive urine or serum pregnancy test at the Screening Visit.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Study Officials

• Shun Lu, Dr.

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingxing Liu

CONTACT

+86 18652105536; liuxx2@hspharm.com

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: June 8, 2023
• First Posted: June 22, 2023
• Study Start: March 2, 2023
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2027
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)