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A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors

NCT05084859 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-09

No results posted yet for this study

Summary

This study is an open-label, multi-center, dose-escalation, dose expansion study in adult subjects with advanced solid tumors. The study will evaluate the safety, tolerability, PK, and preliminary anti-tumor efficacy of SM08502 administered orally (PO), once daily (QD), following a 5 days on 2 days off treatment schedule in combination with chemotherapy or hormonal therapy. Alternative dosing schedules may be explored in Part 1 if necessary. The recommended Part 2 dose and schedule for each combination will then be further evaluated in the Part 2 expansion.

Dosing will occur in 21- or 28-day cycles (depending on the combination partner) and treatment with SM08502 will continue within each subject unless treatment is discontinued due to toxicity, disease progression, initiation of a new anti-neoplastic therapy, withdrawal of consent, the Sponsor terminates the study, or the subject no longer meets retreatment criteria.

Conditions

Interventions

DRUG

SM08502

SM08502 to be administered orally.

DRUG

Abiraterone

Abiraterone to be administered orally.

DRUG

Prednisone

Prednisone to be administered orally.

DRUG

Docetaxel

Docetaxel to be administered intravenously.

DRUG

FOLFIRI Protocol

FOLFIRI Protocol to be administered intravenously.

DRUG

Panitumumab

Panitumumab to be administered intravenously.

Sponsors & Collaborators

  • Biosplice Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Darrin Beaupre, MD, PhD, CMO · Biosplice Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2022-10-20
Completion
2022-10-20
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05084859 on ClinicalTrials.gov