Neoplasms

Digestive System Diseases

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Anus Neoplasms

Rectal Neoplasms

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Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

TP-1454 monotherapy

Jian Li, MD

This study will evaluate the safety and tolerability of oral TP-1454 in patients with advanced metastatic or progressive solid tumors and anal cancer.

Primary Objective:

• To establish the MTD and/or Recommended Phase 2 Dose (RP2D) of orally administered TP-1454 in patients with metastatic solid tumors and anal cancer.

Secondary Objectives:

* To establish the pharmacokinetic (PK) profile of orally administered TP-1454
* To observe patients for any evidence of antitumor activity of TP 1454 by objective radiographic assessment
* To assess the safety and tolerability of TP-1454

Phase 1 Study of Oral TP-1454

A Phase I, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP 1454

MTD will be determined based upon toxicity grades which are defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.

To establish the RP2D for future studies with TP-1454. MTD, PK and PD data to be reviewed.

A DLT is defined as a drug-related toxicity that is observed to occur within the first 28 days

Objective radiographic assessment to be performed to determine antitumor activity by Response Evaluation Criteria in Solid Tumors (RECIST criteria v 1.1).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1 Study of Oral TP-1454	NCT04328740	Advanced Solid ... Anal Cancer	TP-1454 monothe...	18 Years -	Sumitomo Pharma America, Inc.
Phase 1 Study of Oral TP-1454	NCT04328740	Advanced Solid ... Anal Cancer	TP-1454 monothe...	18 Years -	Sumitomo Pharma America, Inc.

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