Solid Tumor (Phase I)Phase 1NCT07842445
Phase 1a/1b Clinical Trials to Evaluate the Safety and Preliminary Efficacy of GNTbm-38.
A Phase 1 study testing GNTbm-38 in people with Solid Tumor (Phase I) and Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL), run by Great Novel Therapeutics Biotech & Medicals Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor (Phase I), Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
- What is being tested?
- GNTbm-38
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Bilirubin ≤ 1.5 × ULN.
- ALP, AST and ALT ≤ 3.0 × ULN (≤ 5.0 × ULN if liver has tumor involvement).
- PT-INR/PTT ≤ 1.5 × ULN.
- All toxicities associated with previous chemotherapy, antibody, or radiotherapy must have recovered to Grade 1 or less (CTCAE Version 6.0), except for alopecia. The following minimum intervals must have elapsed between prior treatment and initiation of IP:
- Chemotherapy: 4 weeks.
- Mitomycin C or Nitrosourea: 6 weeks.
- Radiotherapy: 4 weeks.
- Major surgery: 4 weeks.
- Immunomodulatory drugs: 4 weeks.
- Any antibody agent (Phase Ib): 4 weeks.
- Autologous stem cell transplantation (ASCT): 12 weeks.
- Hormonal therapy: 4 weeks.
Who cannot join
- 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.
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- 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:
- 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.
- 6. Known central nervous system (CNS) involvement, including primary CNS lymphoma or brain metastases.
- 7. 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.
- 10. 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.
- 11. Have been treated with HDAC inhibitors. 12.Subjects with a history of seizures. 13.HBsAg-positive or HCV-Ab-positive. 14. Seropositivity for HIV antibody or known history of HIV/AIDS. 15. History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled peptic ulcer disease, or recurrent pleural effusion requiring repetitive palliative thoracentesis.
- 16. History of immune-mediated toxicity leading to treatment discontinuation. 17. Women who are pregnant or breastfeeding. 18. Female participants who do not agree to refrain from donating oocytes or embryos during treatment and for 90 days after the last dose.
- 19. Male participants who are sexually active with a WOCBP partner and are unwilling or unable to use a condom and ensure that their partner uses at least one highly effective method of contraception during the same period.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1a/1b, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GNTbm 38 in Solid Tumors and Relapsed/Refractory Peripheral T-Cell Lymphoma.
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.
Read the detailed description
This study aims to investigate the maximum tolerated dose, safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of GNTbm-38. 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 in which optimal design is utilized to evaluate the safety, tolerability, and efficacy of GNTbm-38 in R/R PTCL patients.
- Being tested
- GNTbm-38
- Keywords
- GNTbm-38, R/R PTCL
- Medical subject headings
- Recurrence, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNTbm-38Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GNTbm-38 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (4)
Maximum plasma concentration (Cmax)
To characterize the PK of GNTbm-38
Measured: At the end of Cycle 1 (each cycle is 28 days)
Time to reach maximum concentration (Tmax)
To characterize the PK of GNTbm-38
Measured: At the end of cycle 1 (each cycle is 28 days)
Area under the plasma concentration-time curve (AUC)
To characterize the PK of GNTbm-38
Measured: At the end of Cycle 1 (each cycle is 28 days)
Trough concentration (Ctrough)
To characterize the PK of GNTbm-38
Measured: From Cycle 1 Day 1 (each cycle is 28 days) until End of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor (Phase I)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Novel Therapeutics Biotech & Medicals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842445
- Sponsor's protocol ID
- GNTbm-38-001
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 1. Protecting R\&D data and intellectual property. 2. A data sharing platform has not yet been established. 3. The experiment is still in the early stages of exploratory research.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GNTbm 38 in Solid Tumors and Relapsed/Refractory Peripheral T-Cell Lymphoma.
- ClinicalTrials.gov ID
- NCT07842445
- Acronym / sponsor ID
- GNTbm-38-001
- Keywords
- GNTbm-38, R/R PTCL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Great Novel Therapeutics Biotech & Medicals CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to investigate the maximum tolerated dose, safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of GNTbm-38. 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 in which optimal design is utilized to evaluate the safety, tolerability, and efficacy of GNTbm-38 in R/R PTCL patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| To evaluate the MTD and the safety of GNTbm-38 in solid tumor and R/R PTCL | Experimental | Drug: GNTbm-38Patients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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.
Key exclusion criteria (18 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNTbm-38Phase 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. | Drug | To evaluate the MTD and the safety of GNTbm-38 in solid tumor and R/R PTCL |
Primary outcome
Phase 1a: The MTD and DLT of GNTbm-38
Time frame: At the end of Cycle 1 (each cycle is 28 days)
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.
Phase Ia: To define the safety and tolerability
Time frame: At the end of Cycle 1 (each cycle is 28 days)
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.
Phase Ib: To evaluate the efficacy of GNTbm-38 in patients with R/R PTCL.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
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.
4 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Time to reach maximum concentration (Tmax)
Time frame: At the end of cycle 1 (each cycle is 28 days)
Area under the plasma concentration-time curve (AUC)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Trough concentration (Ctrough)
Time frame: From Cycle 1 Day 1 (each cycle is 28 days) until End of Treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. 1. Protecting R\&D data and intellectual property. 2. A data sharing platform has not yet been established. 3. The experiment is still in the early stages of exploratory research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GNTbm-38 in people with Solid Tumor (Phase I) and Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL), run by Great Novel Therapeutics Biotech & Medicals Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Jia-Shiong, Vice President (+886-2-27851399 ext. 301, jschen@gntbm.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: The MTD and DLT of GNTbm-38 (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.