A Phase 1a / 1b Study of Oral TP-0903 in Patients with Advanced Solid Tumors
- Conditions
- advanced metastatic or progressive solid tumor(s)
- Registration Number
- JPRN-jRCT2080224717
- Lead Sponsor
- Sumitomo Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 160
Phase 1a:
Patients with unresectable advanced solid tumors who have shown disease progression after receiving standard/ approved chemotherapy
etc.
Phase 1b:
Patients with unresectable advanced solid tumors and one of the following tumor types:
a. Have progressed after IO therapy and are felt to be appropriate for this type of treatment
b. Have EGFR+ NSCLC and have demonstrated recent progression on <=2 lines of oral TKIs and are felt to be appropriate for this type of treatment.
c. Have BRAF-, KRAS-, or NRAS-mutated CRC, have received no more than 3 previous lines of treatment, and for whom there is no standard therapy remaining
d. Have persistent/recurrent ovarian cancer who would be platinum refractory/ resistant and have had any number of lines of prior therapy
e. Have BRAF-mutated or BRAF wild-type melanoma that has progressed following IO therapy or a combination BRAF/MEK inhibitor therapy
etc.
- Severe heart disease, lung disease, or seizure disease that require treatment with antiepileptic drugs
- Major surgery or radiation therapy within 2 weeks prior to the start date
- Significant surgery to the gastrointestinal tract that could impair absorption
- Pregnant or nursing
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs)
- Secondary Outcome Measures
Name Time Method efficacy<br>exploratory<br>pharmacokinetics<br>pharmacodynamics<br>pharmacogenomics<br>- To evaluate the pharmacokinetics of orally administered TP-0903<br>- To evaluate antitumor activity of TP-0903 by objective radiographic assessment<br>- To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903