A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies

Phase 1RecruitingNCT07197554

SEED Therapeutics, Inc.171 enrolled

Overview

A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies

This Phase 1/1b study is evaluating the safety, tolerability, and preliminary anticancer activity of ST-01156 in participants with advanced solid malignancies. The study will be conducted in 2 parts. Part 1 (Dose Escalation) will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anticancer activity of SD-01156 in participants with advanced solid malignancies, many of whom have a biological rationale to be targeted with an inhibitor of RBM39. Part 1 will also seek to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ST-01156.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

171

Conditions

Advanced Solid Tumors Ewing Sarcoma Hepatocellular Carcinoma (HCC)Biliary Tract Cancer (BTC)

Interventions

ST-01156DRUG

ST-01156 is an orally administered degrader of RBM39, a protein frequently upregulated in cancer

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years on the day of signing the consent form, except for adolescents with Ewing Sarcoma or other malignancies for which there is a biological rationale to support participation, in which case the participant is ≥ 16 years old. * Has a metastatic or locally advanced and unresectable solid tumor. * Has at least 1 measurable lesion or evaluable disease per RECIST v1.1. * Has an ECOG performance status ≤ 2 at screening. * Has adequate organ function as defined in the protocol. Exclusion Criteria: * Has received prior radiotherapy within 2 weeks of treatment. * Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate, provided they are radiologically stable * Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days or 5 half-lives, whichever is shorter. * Had major surgery within 28 days before study therapy administration * Has toxicities from previous anticancer therapies that have not resolved to baseline levels, with the exception of alopecia and peripheral neuropathy. * Has previously received a RBM39 inhibitor/degrader.

Locations (6)

The City of Hope National Medical Center

Duarte, California, United States

RECRUITING

Hoag Memorial Hospital

Newport Beach, California, United States

RECRUITING

Mass General Brigham Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Part 1: Dose Escalation

To characterize the safety, tolerability, and adverse event (AE) profile of escalating doses of ST-01156 administered for 5 consecutive days followed by 2 days without study drug administration every 7 days, with a cycle defined as 28 days (4 weeks).

Time frame: First 28 days of treatment

Part 1: Dose Escalation

To identify the maximum tolerated dose (MTD) or maximum administered dose (MAD), and to recommend a dose for subsequent studies (recommended Phase 2 dose \[ RP2D\]) of ST-01156 on a daily oral schedule for 5 consecutive days out of every 7 days with a cycle defined as 28 days (4 weeks).

Time frame: Duration of treatment period

Secondary Outcomes

Part 1: Dose Escalation

To characterize the pharmacokinetics (PK) of ST-01156 administered on a daily oral schedule for 5 consecutive days every 7 days with cycle defined as 28 days (4 weeks). PK parameters will include area under the concentration-time curve (AUC), maximum observed concentration (Cmax), and time to observe maximum observed concentration (Tmax).

Time frame: First 28 days of treatment

Part 1: Dose Escalation

To detect preliminary evidence of antitumor activity in select advanced cancers where strong preclinical evidence of the anticancer activity of RBM39 degradation is strongest including: * Adults or adolescents with ES following disease progression or intolerance to therapeutics of reasonable likelihood of conferring clinical benefit. * aHCC following disease progression or intolerance to appropriate standard therapy for advanced disease. * KRASm solid malignancy of any type - locally advanced or unresectable solid malignancy following disease progression or intolerance to therapeutics or reasonable likelihood of conferring clinical benefit. * BTC, endometrial carcinoma, solid malignancies with pathogenic somatic or germline mutations in BCRA1/2 or HRR genes (BRCA1/2, PALB2, RAD51C, RAD51D, ATM, BARD1, BLM, BRIP 1, CDK12,FANCA, FANCC, FANCD2, FANCE, FANCF, FANCM, MRE11A, NBN (NBS1), RAD50, RAD51B and others as confirmed by a Clinical Laboratory Improvement Amendments \[CLIA\]-certified m

Central Contacts

Dr. Eric Rowinsky Chief Medical Officer

CONTACT

(908) 883-0647 erowinsky@oncodrugs.com

Data from ClinicalTrials.gov

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