Phase 1a/1b Clinical Trials to Evaluate the Safety and Preliminary Efficacy of GNTbm-38.

NCT07842445 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: GNTbm-38-001
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of GNTbm-38 in adult patients with advanced solid tumors and R/R PTCL.

Conditions

Solid Tumor (Phase I); Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Keywords

GNTbm-38; R/R PTCL

Outcome Measures

Primary Outcomes (3)

• Phase 1a: The MTD and DLT of GNTbm-38

  The primary endpoint of the Phase 1a portion of the study was the incidence and severity of dose-limiting toxicities (DLTs) of GNTbm-38 administered orally once daily during the first cycle of evaluation (each cycle is 28 days). The efficacy assessments will be define by RECIST v1.1.

  At the end of Cycle 1 (each cycle is 28 days)

• Phase Ia: To define the safety and tolerability

  To evaluate the efficacy of GNTbm-38 via analysis of anti-tumor activity in adult patients with Relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). The efficacy assessments will be define by 2014 Lugano classification.

  At the end of Cycle 1 (each cycle is 28 days)

• Phase Ib: To evaluate the efficacy of GNTbm-38 in patients with R/R PTCL.

  Phase 1b dose expansion cohort will be initiated following the MTD from Phase Ia to further evaluate the safety and preliminary efficacy of GNTbm-38 in patients with R/R PTCL, response will be defined by the Lugano criteria.

  At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (4)

• Maximum plasma concentration (Cmax)

  At the end of Cycle 1 (each cycle is 28 days)

• Time to reach maximum concentration (Tmax)

  At the end of cycle 1 (each cycle is 28 days)

• Area under the plasma concentration-time curve (AUC)

  At the end of Cycle 1 (each cycle is 28 days)

• Trough concentration (Ctrough)

  From Cycle 1 Day 1 (each cycle is 28 days) until End of Treatment

Study Arms (1)

To evaluate the MTD and the safety of GNTbm-38 in solid tumor and R/R PTCL

EXPERIMENTAL

Patients will be given GNTbm-38 capsules administered orally once a day with the following dose levels (if applicable): 2.5, 5, 7.5, 10, 12.5, 15, 20, 25 and 30 mg.

Drug: GNTbm-38

Interventions

GNTbm-38 DRUG

Phase 1a is the dose escalation phase to firstly determine the MTD of patients with solid tumor. Once MTD for solid tumor patients has been established, the next lower dose of this MTD will serve as an initial dose to determine the MTD for patients with R/R PTCL. Phase 1b is the dose expansion phase to evaluate the safety, tolerability, and efficacy of GNTbm-38 in R/R PTCL patients.

To evaluate the MTD and the safety of GNTbm-38 in solid tumor and R/R PTCL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and/or male aged ≥ 18 to ≤ 75 years.
• Histologically or cytologically proven advanced solid tumors or R/R PTCL. For solid tumors, patients must have relapsed or refractory disease after failure of all standard therapies. For R/R PTCL, PTCL subtypes as defined by the WHO classification of tumors (Swerdlow 2022) may be included: PTCL, not otherwise specified (PTCL-NOS), anaplastic lymphoma kinase-positive (ALK+) anaplastic large-cell lymphoma (ALCL), ALK-negative (ALK-) ALCL, angioimmunoblastic T-cell lymphoma (AITL), etc., except cutaneous form, leukemic form and extra-nodal natural killer (NK)/T-cell lymphoma, nasal type (ENKL). R/R PTCL patients must have relapsed or have refractory disease after at least one line of systemic therapy. Patients with CD30+ PTCL should have received a CD30-targeted agent when applicable, and patients with ALK+ ALCL should have received an ALK inhibitor.
• ECOG performance status of 0 to 2.
• Estimated life expectancy of \> 3 months.
• At least 1 measurable lesion confirmed prior to IP administration.
• At the discretion of the Investigator or designee, in good general health with no significant medical history and no clinically significant abnormalities.
• BMI between ≥ 18.0 and ≤ 30.0 kg/m² and weight ≥ 50 kg.
• Laboratory values must meet the following criteria:
• Calculated creatinine clearance \> 60 mL/min.
• Proteinuria \< 2+ or ≤ 500 mg/24 hours if dipstick ≥ 2+.
• Potassium and corrected calcium within normal limits.
• Troponin I ≤ upper limit of normal (ULN).
• Absolute neutrophil count ≥ 1.5 × 10⁹/L for patients with solid tumors, or Absolute neutrophil count of ≥ 1.0 × 10⁹/L for patients with R/R PTCL.
• Hemoglobin ≥ 9.0 g/dL.
• Platelets ≥ 90 × 10⁹/L.

You may not qualify if:

• Underlying physical or psychological medical condition that, in the opinion of the Investigator, would make the patient unlikely to comply with the protocol or complete the study.
• Blood or plasma donation or significant blood loss within 30 days prior to the first administration of IP.
• Fever (body temperature \> 38°C) or symptomatic viral or bacterial infection within 1 week prior to Screening.
• Infections requiring parenteral antibiotics within 4 weeks prior to Screening.
• History of any other secondary malignancies unless:
• Non-melanoma skin cancer excised more than 2 years ago.
• Cervical intraepithelial neoplasia cured more than 5 years ago.
• Carcinoma in situ of the cervix treated with curative intent.
• Curatively treated prostate cancer with PSA \< 0.1 ng/mL.
• Second malignancy in remission for ≥ 2 years.
• Participants will be excluded if any of the following are present in the screening ECG or cardiac evaluation:
• a. QTc prolongation \> CTCAE Grade 1, or history of congenital long QT syndrome b. Clinically significant cardiac arrhythmias. d. Any other ECG abnormality that, in opinion, of the investigator, would pose an unacceptable risk with GNTbm-38.
• \. Known central nervous system (CNS) involvement, including primary CNS lymphoma or brain metastases.
• \. Organ transplant recipients. 8. Allogeneic stem cell transplant recipients. 9. Use of any strong inhibitor or strong inducer of CYP3A4, P gp, and/or BCRP is not permitted.
• \. Patients using heparin or warfarin/Coumadin-type anticoagulants; however, low-dose (\< 2 mg) Coumadin for portacath patency or low-dose subcutaneous heparin for thrombophlebitis prophylaxis are allowed.

Sponsors & Collaborators

• Great Novel Therapeutics Biotech & Medicals Corporation: lead

MeSH Terms

Conditions

Recurrence; Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Chen Jia-Shiong, Vice President

CONTACT

+886-2-27851399; jschen@gntbm.com.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: September 25, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share