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Trial NCT06975293

STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas

Phase
Phase 1/2
Sponsor
STORM Therapeutics LTD
Conditions
Solid Tumor; Sarcoma; Leiomyosarcoma; Dedifferentiated Liposarcoma
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Key Inclusion Criteria: * Estimated life expectancy ≥ 3 months. * ECOG performance status 0 or 1.Performance status * Measurable disease according to RECIST v1.1 as assessed by the local site investigator/radiology. * Documented radiologic assessment of progression on the prior therapy before study entry. * Have adequate organ function. * Have the ability to swallow, retain, and absorb oral medication. Inclusion Criteria (Phase 2 Monotherapy Cohorts): * Have histologic or cytologic confirmation of advanced sarcoma of the selected histologic subtype that is not amenable to local curative therapy. Participant must have received at least 2, but no more than 4 prior lines of systemic therapy. * Pre-treatment and on-treatment biopsy if medically feasible. Key Exclusion Criteria: * Pregnant and lactating women.Pregnancy * Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to first IMP administration. * Participants who have not recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline, according to NCI-CTCAE v5.0. Exceptions include: alopecia, Grade ≤ 2 neuropathy, and endocrine-related AEs Grade ≤ 2 who are stable on treatment or hormone replacement. * History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or the presence of ongoing pneumonitis/interstitial lung disease). * Clinically significant cardiovascular disease or condition.Cardiac * Known active CNS metastases and/or leptomeningeal disease.Brain metastases

Restrictions found (4)

Recruiting in Massachusetts

  • Dana Farber Cancer Institute · Boston, Suffolk County