臨床研究等提出・公開システム

A Study to Evaluate CTX-712 in Advanced, Relapsed or Refractory Malignant Cancer Patients

A Study to Evaluate CTX-712 in Advanced, Relapsed or Refractory Malignant Cancer Patients

Chordia Therapeutics Inc.

26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa

clinical@chordiatherapeutics.com

Chordia Therapeutics Inc.

26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa

+81-466-52-7522

clinical@chordiatherapeutics.com

completed

Nov. 14, 2018

Interventional

Phase 1, Open-label, Non-controlled, Multi-center, Repeat dose, Dose escalation study

treatment purpose

1

1) Subjects must have an advanced, relapsed or refractory cancer
- For a cohort of hematological cancers,subjects must have an MDS, CMML or AML (excluding APL) according to World Health Organization (WHO) criteria.
- As for MDS, subjects must be considered an intermediate, high, or very high risk according to the Revised International Prognostic Scoring System (IPSS-R)
2) Subjects must relapse or refractory to standard therapies, or not eligible for standard therapies.
3) Subjects must be an eastern cooperative oncology group (ECOG) performance status of 0 or 1
4) Subjects must have more than 90 days life expectancy
5) Subjects must have adequate major organ functions

1) Patients with uncontrolled complications
2) Patients with active multiple primary cancers that require specific treatments
3) In a cohort of hematologic cancer patients, those who have received allogenic hematopoietic stem cell transplantation
4) Patients having a medical history of congenital retinal degenerative disease,optic nerve or retinal diseases

Both

Advanced,relapsed or refractory cancers

investigational material(s)
Generic name etc : CTX-712
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Cohort A (Dose Escalation Cohort, included: solid tumors)
CTX-712 will be orally administrated twice a week (planned at 10mg, 20mg, 40mg, 80mg, 115mg, 140mg, 160mg but not limited to these doses)
Cohort B (Dose Escalation Cohort, included: hematologic malignancies)
CTX-712 will be orally administrated twice a week at 105mg and dose escalation will continue
Cohort C (Expanded Cohort, included: solid tumors)
CTX-712 will be orally administrated twice a week at 105mg
Cohort D (Expanded Cohort, included: ovarian cancer, endometrial cancer, prostate cancer, breast cancer, and NSCLC)
CTX-712 will be orally administrated twice a week at 70mg
Cohort E (Expanded Cohort, included: ovarian cancer, endometrial cancer, prostate cancer, breast cancer, and NSCLC)
CTX-712 will be orally administrated at 105mg weekly

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

safety
efficacy
Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT)

pharmacokinetics
pharmacodynamics
pharmacokinetics (PK) and pharmacodynamics (PD) profile

+81-3-3542-2511

Nov. 07, 2018