A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
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 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
Single group
ST-01156
DrugST-01156 is an orally administered degrader of RBM39, a protein frequently upregulated in cancer
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).
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).
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).
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
Part 1: Dose Escalation
To evaluate the relationship between RBM39 degradation in peripheral blood mononuclear cells (PBMC) \[and potentially other cells or tissues\], to various safety and efficacy endpoints.
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