Clinical trial · Interventional
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Patients With Advanced Solid Tumors
NCT06959706CI-TRIAL-00108488recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objectives of this study are to evaluate the safety and tolerability of TGW101 and determine the recommended dosing regimen(s) for further study. The secondary objectives are to assess pharmacokinetics and preliminary antitumor activity.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TGW101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TGW101: Dose Escalation Cohorts
- description
- Escalating doses of TGW101-anti-drug conjugate (ADC) will be administered via intravenous (IV) infusion followed by administration of TRG001. The treatment period continues until a reason for permanent discontinuation of treatment occurs.
- interventionNames
- Drug: TGW101
- type
- EXPERIMENTAL
- label
- TGW101: Enrichment Cohorts
- description
- During Dose Escalation, additional participants may be enrolled to permit further evaluation of TGW101 to support selection of the optimal recommended dosing regimen(s) for expansion (RDE\[s\]). At the discretion of the Safety Oversight Committee (SOC), enrollment in enrichment cohorts may be limited to specific tumor type(s) based on assessment of clinical activity by the Sponsor in the dose escalation portion, and other nonclinical, translational, and clinical data.
- interventionNames
- Drug: TGW101
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent prior to any study procedures. 2. Males or females 18 years or older. 3. Histologically or cytologically confirmed diagnosis of a solid tumor malignancy listed below, with radiographic evidence of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or for castration resistant prostate cancer (CRPC), Prostate Cancer Clinical Trials Working Group 3, after most recent treatment and locally advanced or metastatic disease at Screening: 1. Breast cancer (all subtypes). 2. Castrate-resistant prostate cancer. 3. Cervical cancer. 4. Endometrial cancer. 5. Esophageal, adenocarcinoma only. 6. Gastric/gastroesophageal junction (GEJ). 7. Non-squamous cell carcinoma of the head and neck, e.g., salivary gland neoplasms, with the exception of adenoid cystic carcinoma. 8. Non-small cell lung cancer, adenocarcinoma only. 9. Ovarian. 4. Refractory disease, intolerance to, or documented refusal of available standard therapy(ies) known to provide clinical benefit for the participant's solid tumor malignancy per Investigator judgment. 5. At least 1 measurable lesion per RECIST v1.1 except for participants with bone-only metastatic disease. 6. Biopsy pretreatment; if not possible, archival tissue block (preferred) or unstained formalin-fixed paraffin-embedded slides required. 7. Eastern Cooperative Oncology Group Performance Status 0-1. 8. Life expectancy of \> 3 months in the opinion of the Investigator. 9. Adequate hepatic, hematologic, and renal function. Exclusion Criteria: 1. Active second malignancy or history of another malignancy within the last 2 years, with the exception of: treated non-melanoma skin cancers; treated carcinoma in situ (e.g., breast and cervix); controlled superficial carcinoma of the urinary bladder; T1a or b carcinoma of the prostate; papillary thyroid carcinoma Stage I treated surgically for cure. 2. Known symptomatic brain metastases. 3. Significant cardiovascular disease within 6 months prior to starting study drug. 4. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment. 5. Grade ≥ 2 peripheral neuropathy. 6. Major surgery within 4 weeks prior to starting study drug. 7. Prior solid organ or bone marrow progenitor cell transplantation. 8. Prior high-dose chemotherapy requiring stem cell rescue. 9. Anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to starting study drug. 10. Palliative radiation therapy within 14 days prior to starting study drug. 11. Live vaccine within 28 days prior to starting study drug. 12. Pregnant or a breastfeeding postpartum female.
References
Publications (0)
Data not yet available
No reference posted for this study.