Colon Cancer Clinical Trial

A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors

Summary

This is an open-label, two-part, phase 1-2 study designed to determine the safety, tolerability, PK, pharmacodynamics (PD), and proof-of-concept efficacy of ST316 administered IV in subjects with selected advanced solid tumors likely to harbor abnormalities of the WNT/β-catenin signaling pathway. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Able and willing to sign ICF and comply with the protocol and the restrictions and assessments therein.
Male or female ≥18 years of age.
ECOG performance status 0-1.

Must have a locally advanced or metastatic inoperable tumor as follows:

For the dose escalation/regimen exploration phase: CRC, BC, NSCLC, OC, pancreatic adenocarcinoma, melanoma, CC, and synovial sarcoma.
For the expansion phase: CRC

Agrees to provide a newly obtained biopsy of an accessible lesion (if they can be biopsied based on the Investigator's assessment) prior to the start of study treatment, and to repeat biopsy once during study treatment. Tissue obtained for the biopsy must not be previously irradiated, but a new or progressing lesion in the radiation field is acceptable. Subjects without accessible lesion for biopsy must be able to provide an archival tumor tissue sample for central lab analysis.

a. For the dose escalation/regimen exploration phase: i. Refractory, intolerant, or refused all available standard-of-care therapies ii. Up to 3 previous lines of systemic anticancer therapies for metastatic disease are allowed.

iii. Patients with TNBC or OC with known BRCA mutations must have been previously treated with or intolerant to FDA approved treatments prior to enrolling in this study (e.g. iPARP).

iv. Patients with OC must have been treated with, refused, or were ineligible for treatment with bevacizumab to enroll.

v. Patients with CRC tumors that are MSI-H/dMMR must have received, refused or be intolerant to a check point inhibitor.

b. For the expansion phase: i. For all cohorts: Subjects with MSI-H/dMMR must have received, refused or be intolerant to a CPI.

ii. Cohort 1 monotherapy: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of 4 prior lines of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines, anti-vascular-endothelial growth factor (VEGF), anti-epidermal growth factor receptor (EGFR) targeted agents (as indicated).

iii. Cohort 2: Combination with standard of care (SOC) FOLFIRI + bevacizumab: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of 1 prior line of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF. Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first line of treatment.

iv. Cohort 3: Combination with fruquintinib: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of 3 prior lines of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF, regorafenib or lonsurf. Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first line of treatment.

Exclusion Criteria:

Known hypersensitivity to ST316 or any of its excipients.
Corrected interval between Q and T wave on ECG (QTc) > 480 msec using Fredericia's formula.
Symptomatic ascites or pleural effusion. A subject who is clinically stable for 4 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
Known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks prior to study entry and have no evidence of new or enlarging brain metastases. Subjects with treated brain metastases must also follow the steroid exclusion criterion (#9) listed below.
For expansion phase only: presence of any other active malignancy requiring systemic therapy other than the disease under study.
Concurrent anti-cancer therapy.
Known HIV and positive -

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

115

Study ID:

NCT05848739

Recruitment Status:

Recruiting

Sponsor:

Sapience Therapeutics

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There are 5 Locations for this study

See Locations Near You

USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Stephanie Kim
Contact
[email protected]
Anthoney El-Khoueiry, MD
Principal Investigator
Sarah Cannon Research Institute - CO
Denver Colorado, 80218, United States More Info
Tamara Davidson, MD
Contact
[email protected]
Jason Henry, MD
Principal Investigator
START Midwest
Grand Rapids Michigan, 49503, United States More Info
Julie Burns, BSN
Contact
[email protected]
Nehal Lakhani, MD
Principal Investigator
Duke Universtiy
Durham North Carolina, 27708, United States More Info
JoAnna Gontarz, MSN
Contact
[email protected]
Niharika Mettu, MD PhD
Principal Investigator
Sanford Cancer Center
Sioux Falls South Dakota, 57104, United States More Info
Staci Vogel
Contact
605-312-3320
[email protected]
Steven Powell, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

115

Study ID:

NCT05848739

Recruitment Status:

Recruiting

Sponsor:


Sapience Therapeutics

How clear is this clinincal trial information?

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