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

63

Safety Analysis Population Solid Tumor Sex: Women [27 (58.7%)], men [19 (41.3%)] Age: Median: 56.0 years Race: Asian [46 (100%)] Hematologic Malignancies Sex: Women [1 (7.1%)], men [13 (92.9%)] Age: Median: 71.0 years Race: Asian [14 (100%)]

Solid Tumor Out of 48 total patients enrolled, 46 patients received treatment (10, 20, 40, 70, 105, 140 and 175 mg BIW, and 105 mg QW), and all patients eventually discontinued treatment. Hematologic Malignancies Out of 15 total patients enrolled, 14 patients received treatment (70 and 105 mg BIW), and all patients eventually discontinued treatment.

Solid Tumor Hypokalaemia (Grade 3) and platelet count decreased (Grade 3) were evaluated as DLT in 1 of 6 subjects (16.7%) each at 140 mg, and dehydration (Grade 3) was evaluated as DLT in 1 of 3 subjects (33.3%) at 175 mg. The MTD for solid tumors was concluded to be 140 mg. Hematologic Malignancies Pneumonia (Grade 4) was evaluated as DLT in 1 of 3 subjects (33.3%) at 105 mg. No DLT was observed at 70 mg.

Primary Outcome Measures: For the solid tumor cohort, hypokalaemia (Grade 3) and platelet count decreased (Grade 3) were evaluated as DLT in 1 of 6 subjects (16.7%) each at 140 mg, and dehydration (Grade 3) was evaluated as DLT in 1 of 3 subjects (33.3%) at 175 mg. The MTD for solid tumors was concluded to be 140 mg. For the hematologic malignancies cohort, pneumonia (Grade 4) was evaluated as DLT in 1 of 3 subjects (33.3%) at 105 mg. No DLT was observed at 70 mg.

Secondary Outcome Measures: PR was observed in 3 patients with ovarian cancer, and CR/CRi was observed in 5 patients with hematologic malignancies (3 CR/1 CRi in AML and 1 CR in MDS). The median OS in the solid tumor cohort and the hematologic malignancies cohort was 9.61 months (95% CI: 6.28 months-Not Reached) and 10.40 months (95% CI: 2.99 months-Not Reached), respectively.

In the solid tumor cohort, 48 patients were enrolled and 46 treated at 10-175 mg. DLTs at 140 mg included Grade 3 hypokalaemia and thrombocytopenia (16.7% each), and Grade 3 dehydration occurred in 33.3% at 175 mg; MTD was 140 mg. In hematologic malignancies, 14 patients received 70 or 105 mg; Grade 4 pneumonia was observed at 105 mg. Partial responses occurred in ovarian cancer, and CR/CRi in hematologic malignancies. Median OS was 9.61 and 10.40 months, respectively.

Oct. 14, 2025

https://ashpublications.org/bloodadvances/article/10/1/262/547633/Phase-1-study-of-rogocekib-in-patients-with

No

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