First in Human Study of TUB-030 in Patients with Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors; HNSCC; SCLC; NSCLC; TNBC - Triple-Negative Breast Cancer; CRC
• Interventions: Drug: TUB-030

• Registration Number: NCT06657222
• Lead Sponsor: Tubulis GmbH

Brief Summary

The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are:

To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose.

Participants will:

Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-22
• Study First Posted: 2024-10-24
• Study Start: 2024-12-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Male or non-pregnant, non-breastfeeding female aged 18 years or older
2. Adequate organ function
3. Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter, before C1D1
4. AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.
5. For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.
6. For patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to C1D1. For patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to C1D1.
7. Radiologically measurable disease by RECIST v1.1, 4 weeks before C1D1, that can include a lesion in an irradiated field that shows progression according to RECIST v1.1 after irradiation.
8. Eastern Cooperative Oncology Group (ECOG) 0-1.
9. Have a life expectancy of >12 weeks for disease-related mortality, as evaluated by the INV.
10. In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent
11. Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1: dose escalation	TUB-030	Drug TUB-030, administered by intravenous (IV) infusion
Phase 2: dose optimization in NSCLC and HNSCC	TUB-030	Drug TUB-030, administered by intravenous (IV) infusion NSCLC Cohort: Patients will be randomized to receive one of two doses administered by IV infusion HNSCC Cohort: Patients will be randomized to receive one of two doses administered by IV infusion

Primary Outcome Measures

Name	Time	Method
Determination of MTD	From enrollment until 30 days after last study drug	The highest dose is defined at which no more than 1 of 3 patients have had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria

Secondary Outcome Measures

Name	Time	Method
Number of patients with Adverse Events (AE)	From enrollment until 30 days after last study drug	Any medical event in a participant which may or may not have a causal relationship with this treatment.
Maximum concentration (Cmax)	From enrollment until 30 days after last study drug	The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
Trough concentration (Cmin)	From enrollment until 30 days after last study drug	The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Cmin will be derived).
The time taken to reach the maximum concentration (Tmax)	From enrollment until 30 days after last study drug	The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Tmax will be derived).
Area Under Curve (AUC)	From enrollment until 30 days after last study drug	PK endpoint
Half life (T1/2)	From enrollment until 30 days after last study drug	PK endpoint
Determination of immunogenicity	From enrollment until 30 days after last study drug	Number and percentage of patients developing anti-TUB-030 antibodies
Determination of efficacy	From enrolment until 30 days after last study drug.	ORR by investigator assest Recist 1.1

Trial Locations

Locations (3)

NEXT Oncology Austin; 🇺🇸 Austin, Texas, United States

NEXT Oncology - Dallas; 🇺🇸 Irving, Texas, United States

NEXT Oncology - San Antonio; 🇺🇸 San Antonio, Texas, United States