臨床研究等提出・公開システム

A Phase 1a / 1b, First-in-human, Open-label,Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors

A Phase 1a / 1b Study of Oral TP-0903 in Patients with Advanced Solid Tumors

Sumitomo Pharma Co., Ltd.

cc@sumitomo-pharma.co.jp

Sumitomo Pharma Co., Ltd.

cc@sumitomo-pharma.co.jp

completed

Aug. 07, 2019

Interventional

a Phase 1a / 1b, open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic (PD) study

treatment purpose

1

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.

Both

advanced metastatic or progressive solid tumor(s)

investigational material(s)
Generic name etc : TP-0903
INN of investigational material : Dubermatinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Oral administration

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs)

efficacy
exploratory
pharmacokinetics
pharmacodynamics
pharmacogenomics
- To evaluate the pharmacokinetics of orally administered TP-0903
- To evaluate antitumor activity of TP-0903 by objective radiographic assessment
- To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903

-

June. 12, 2019