Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors

NCT06686745 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SIM0508-101
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and PK/PD characteristics of SIM0508 as a single agent and in combination with olaparib in participants with locally advanced/metastatic solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT)

  Primary Endpoints

  At the end of Cycle 1 (each cycle is 28 days)

Study Arms (3)

SIM0508 mono dose escalation

EXPERIMENTAL

Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose.

Drug: SIM0508 Tablets

SIM0508 combination dose escalation

EXPERIMENTAL

Every 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.

Drug: SIM0508 in combination with olaparib

SIM0508 in combination with olaparib

EXPERIMENTAL

Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0508 combination with olaparib established from SIM0508 combination dose escalation.

Drug: SIM0508 in combination with olaparib

Interventions

SIM0508 Tablets DRUG

Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose.

SIM0508 mono dose escalation

SIM0508 in combination with olaparib DRUG

Every 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.

SIM0508 combination dose escalation

Eligibility Criteria

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

You may qualify if:

• Voluntary participation and signature of informed consent form.
• Participants with histologically confirmed ovarian cancer, prostate cancer,breast cancer , or pancreatic cancer.
• ECOG score of 0 or 1.
• Expected survival ≥ 12 weeks.

You may not qualify if:

• Active hepatitis B (HBsAg or HBcAb positive and HBV DNA≥1×104 copies/mL or≥2000 international unit \[IU\]/mL) or hepatitis C (HCV antibody positive and HCV RNA≥ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the study.
• Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
• Participants unable to swallow study drug and participants with gastrointestinal disorders likely to interfere with absorption of the study drug.
• Toxicities from previous anticancer therapies have not resolved (e.g to ≤ Grade 1).
• Pregnant or nursing (lactating) women; other women of childbearing potential, unless the blood pregnancy test within 7 days of first dose of study drug is negative, and participants agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 or olaparib, whichever comes later.
• Male partinipants with female partners of reproductive potential, unless they agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 and 90 days after the last dose of olaparib, whichever comes later.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead
• Shanghai Xianxiang Medical Technology Co., Ltd.: collaborator

Study Sites (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

Chongqing Cancer Hospital

Chongqing, China

RECRUITING

MeSH Terms

Interventions

olaparib

Central Study Contacts

Juan Wen Wang

CONTACT

65212241; wangwenjuan4@zaiming.com

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: November 12, 2024
• First Posted: November 13, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

CN (2)