A Study for HSK39775 in Participants With Solid Tumors

NCT06314373 | Recruiting Phase 1

• 1 other identifier: HSK39775-101/201
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• AE/SAE

  Safety data

  From time of informed consent to 28 days post last dose or start of other anti-cancer therapies

• DLT

  Safety data

  From the start of first dose to the end of Cycle1(each cycle is 28 days)

• MTD/MAD

  Safety data

  From the start of first dose to the end of Cycle1(each cycle is 28 days)

Secondary Outcomes (9)

• Maximum Plasma Concentration [Cmax]

  At predefined intervals throughout the treatment period(approximately 12 weeks)

• Area Under Curve[AUC]

  At predefined intervals throughout the treatment period(approximately 12 weeks)

• Time to maximum observed concentration [Tmax]

  At predefined intervals throughout the treatment period(approximately 12 weeks)

• Elimination half-life [t1/2]

  At predefined intervals throughout the treatment period(approximately 12 weeks)

• Overall Response Rate (ORR) per RECIST V1.1

  From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]

Study Arms (2)

Dose Escalation

EXPERIMENTAL

Dose Escalation:Participants will receive escalating doses of HSK39775

Drug: HSK39775 Monotherapy

Cohort Expansion

EXPERIMENTAL

Cohort Expansion:Participants will receive HSK39775 at the identified RP2D

Drug: HSK39775 Monotherapy

Interventions

HSK39775 Monotherapy DRUG

HSK39775 will be administered orally once daily

Cohort Expansion; Dose Escalation

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older at screening
• Histological or cytological confirmation of advanced malignancy, have failed or intolerant to the standard-of-care treatment or no standard therapy is recognized or standard therapy is unavailable
• Eastern Cooperative Oncology Group performance status 0 or 1
• Patients must have evaluable disease as defined
• Life expectancy of ≥ 12 weeks
• Adequate organ and bone marrow function per protocol
• Female patients who are women of childbearing potential with confirmed of a negative pregnancy test within 7 days prior to the first dose and agreement to the use of effective contraceptive method at the same time during study treatment period and for up to 6 months after the last dose of study treatment. Male patients must be willing to use effective contraception during the study treatment period and for up to 6 months after the last dose of study treatment
• Written informed consent must be obtained

You may not qualify if:

• Known allergies to HSK39775 or its excipients
• Prior anticancer treatment is ineligible per protocol
• Subjects who have had continuous corticosteroids at a dose of \>10 mg prednisone/day or equivalent within 4 weeks prior to the first dose of study treatment
• Subjects who have had live vaccine within 4 weeks prior the first dose of study treatment
• Currently participating in a study of another investigational agent or device
• Subjects who have had received another agent with same target
• Subjects who have not recovered (to grade ≤1 or baseline) from toxicities related to prior therapies
• Subjects who have had received drugs that may have drug-drug interaction potential within 4 weeks or 5 half-lives prior to the first dose of study treatment
• Subjects who have had received major surgery within 4 weeks prior the first dose of study treatment
• Central nervous system metastases associated with neurological symptoms
• Active hepatitis B or hepatitis C infection
• A history of immunodeficiency
• Clinically relevant cardiovascular disease as delined by protocol
• Inability to swallow the formulated product or impairment of GI function or disease that may significantly alter the absorption of study drug
• A female patient who is pregnant or lactating

Sponsors & Collaborators

• Xizang Haisco Pharmaceutical Co., Ltd: lead

Study Sites (1)

Fundan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Yong Cao

CONTACT

028-67258840; caoyong@haisco.com

Study Design

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

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 18, 2024
• Study Start: March 7, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)