Colorectal Cancer Clinical Trial
Official title:
A Phase 1 Study of COTI-2 as Monotherapy or Combination Therapy for the Treatment of Advanced or Recurrent Malignancies
Activity of COTI-2 has been demonstrated in various cancer tumor models. With its p53- and
AKT-based mechanisms of action, COTI-2 is anticipated to be highly relevant in treatment of
patients with gynecologic malignancies or head and neck squamous cell carcinoma (HNSCC) as
well as a variety of other tumor types.
This study is designed primarily to assess the safety and tolerability of COTI-2 monotherapy
or combination therapy in patients with advanced and recurrent malignancies to establish a
recommended Phase 2 dose (RP2D) for future studies.
Patients are currently being recruited for Part 3 of the study.
Critical Outcome Technologies Inc. has been renamed to Cotinga Pharmaceuticals.
This is a three-part, multi-center, open-label, Phase 1, first-in-patient study of COTI-2 in
patients with recurrent ovarian, fallopian tube, primary peritoneal, endometrial, or cervical
cancer (collectively gynecological malignancies), and in patients with head and neck squamous
cell carcinoma (HNSCC), colorectal, lung, or pancreatic cancer. Other tumor types may be
allowed with Sponsor approval.
COTI-2 will be self-administered as a single agent, orally, once daily for 5 days followed by
2 treatment-free days each week.
Part 1 of the study will be dose finding in patients with gynecological malignancies using a
3 + 3 design to establish the MTD (maximum tolerated dose) over 6 planned cohorts.
Part 2 of the study will be dose finding in patients with HNSCC using a 3 + 3 design to
establish the MTD over 6 planned cohorts.
Part 3 of the study will be dose finding for COTI-2 in combination with cisplatin in patients
with gynecological malignancies, HNSCC, colorectal, lung, pancreatic cancer, or other tumor
types with Sponsor approval.
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