Advanced Solid Tumors, Biliary Tract Cancer (BTC), Ewing Sarcoma, Hepatocellular Carcinoma (HCC)
Conditions
Keywords
cancer, solid tumors, RBM39, RBM39 degrader, metastatic solid malignancies, Ewing sarcoma, Hepatocellular carcinoma, HCC, Biliary tract carcinoma, endometrial carcinoma, Adolescents
Brief summary
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
Detailed description
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.
Interventions
DRUGST-01156
ST-01156 is an orally administered degrader of RBM39, a protein frequently upregulated in cancer
Sponsors
SEED Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Dose Escalation | First 28 days of treatment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Dose Escalation | First 28 days of treatment | 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). |
Countries
United States
Contacts
CONTACTDr. Eric Rowinsky Chief Medical Officer
Outcome results
None listed