Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
- Registration Number
- NCT06959706
- Lead Sponsor
- Tagworks Pharmaceuticals BV
- Brief Summary
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 anti-tumor activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
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Written informed consent prior to any study procedures.
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Males or females 18 years or older.
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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:
- Breast cancer (triple negative, estrogen receptor and/or progesterone receptor positive, and/or human epidermal growth factor receptor 2 positive).
- Castrate-resistant prostate cancer.
- Cervical cancer.
- Endometrial cancer.
- Esophageal, adenocarcinoma only.
- Gastric.
- Non-squamous cell carcinoma of the head and neck, e.g., salivary gland neoplasms.
- Non-small cell lung cancer, adenocarcinoma only.
- Ovarian.
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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.
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At least 1 measurable lesion per RECIST v1.1 except for participants with bone-only metastatic disease.
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Biopsy pretreatment; if not possible, archival tissue block (preferred) or unstained formalin-fixed paraffin-embedded slides required.
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Eastern Cooperative Oncology Group Performance Status 0-1.
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Life expectancy of > 3 months in the opinion of the Investigator.
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Adequate hepatic, hematologic, and renal function.
- 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.
- Known symptomatic brain metastases.
- Significant cardiovascular disease within 6 months prior to starting study drug.
- Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment.
- Grade ≥ 2 peripheral neuropathy.
- Major surgery within 4 weeks prior to starting study drug.
- Prior solid organ or bone marrow progenitor cell transplantation.
- Prior high-dose chemotherapy requiring stem cell rescue.
- Anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to starting study drug.
- Palliative radiation therapy within 14 days prior to starting study drug.
- Live vaccine within 28 days prior to starting study drug.
- Pregnant or a breastfeeding postpartum female.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description TGW101: Dose Escalation Cohorts TGW101 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. TGW101: Enrichment Cohorts TGW101 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 a Safety Oversight Committee (SOC), enrollment in enrichment cohorts may be limited to specific tumor type(s).
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Dose Reduction Up to approximately 10 months Number of Participants Experiencing Cycle Delay Up to approximately 10 months Number of Participants Experiencing Adverse Events (AEs) Up to approximately 10 months Number of Participants Experiencing Dose Limiting Toxicities (DLTs) Up to Day 21 RDE of TGW101 Up to approximately 10 months
- Secondary Outcome Measures
Name Time Method Steady-state Volume of Distribution (Vss) of TGW101-ADC Related Analytes Up to approximately 10 months Clearance (CL) of TGW101-ADC Related Analytes Up to approximately 10 months Accumulation Index of TGW101-ADC Related Analytes Up to approximately 10 months Overall Response Rate (ORR) Up to approximately 10 months Number of Participants Experiencing Antidrug Antibodies (ADAs) Against TGW101-ADC Up to approximately 10 months Trough Concentration (Ctrough) of TGW101-ADC Related Analytes Up to approximately 10 months Apparent Terminal Elimination Half-life (t1/2) of TGW101-ADC Related Analytes Up to approximately 10 months Time to Maximum Concentration (Tmax) of TGW101-ADC Related Analytes Up to approximately 10 months Duration of Response (DOR) Up to approximately 10 months Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of TGW101-ADC Related Analytes Up to approximately 10 months Area Under the Concentration-time Curve From Time Zero to the end of the Dosing Interval (AUCtau) of TGW101-ADC Related Analytes Up to approximately 10 months Maximum Concentration (Cmax) of TGW101-ADC Related Analytes Up to approximately 10 months Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of TGW101-ADC Related Analytes Up to approximately 10 months Progression-free Survival (PFS) Up to approximately 10 months Overall Survival (OS) Up to approximately 10 months
Trial Locations
- Locations (3)
NEXT Dallas
🇺🇸Irving, Texas, United States
NEXT San Antonio
🇺🇸San Antonio, Texas, United States
NEXT Virginia
🇺🇸Fairfax, Virginia, United States
NEXT Dallas🇺🇸Irving, Texas, United States