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

Conditions

Advanced,relapsed or refractory cancers

Yokoyama H, Fukuhara N, Ando K, Iida H, Yamauchi T, Fukuhara S, Izutsu K, Tanoue Y, Yamamoto M, Tozaki H, Takahara E, Shoji S, Mizutani A, Morishita D, Oda R, Miyake H, Yamamoto N.

2026-01-01

10.1182/bloodadvances.2025017601

Abstract CT115: A first-in-human phase I study of CTX-712 in patients with advanced, relapsed or refractory malignant tumors (CTX-712-CL-01 study): Efficacy and safety in a hematologic malignancies cohort

Hisayuki Yokoyama, Noriko Fukuhara, Koji Ando, Hiroatsu Iida, Takahiro Yamauchi et al. (17 authors)

Cancer Research2024-04-051 citations

10.1158/1538-7445.am2024-ct115

Abstract CT110: A first-in-human phase I study of CTX-712 in patients with advanced, relapsed or refractory malignant tumors (CTX-712-CL-01 study): Efficacy and safety in solid tumor cohorts

Noboru Yamamoto, Takafumi Koyama, Yuki Katsuya, Jun Sato, Toshio Shimizu et al. (15 authors)

Cancer Research2024-04-05

10.1158/1538-7445.am2024-ct110

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
safety efficacy Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT)	—

Secondary

Measure	Time frame
pharmacokinetics pharmacodynamics pharmacokinetics (PK) and pharmacodynamics (PD) profile	—

Countries

Japan

Outcome results

None listed