Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors

Tagworks Pharmaceuticals BV

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: TGW101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06959706

TGW101-101

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (triple negative, estrogen receptor and/or progesterone receptor positive, and/or human epidermal growth factor receptor 2 positive).
   2. Castrate-resistant prostate cancer.
   3. Cervical cancer.
   4. Endometrial cancer.
   5. Esophageal, adenocarcinoma only.
   6. Gastric.
   7. Non-squamous cell carcinoma of the head and neck, e.g., salivary gland neoplasms.
   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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

TGW101: Dose Escalation Cohorts

Experimental group

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.

Treatment:

Drug: TGW101

TGW101: Enrichment Cohorts

Experimental group

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 a Safety Oversight Committee (SOC), enrollment in enrichment cohorts may be limited to specific tumor type(s).

Treatment:

Drug: TGW101