Advanced Solid Tumors, CRC, HNSCC, NSCLC, SCLC, TNBC - Triple-Negative Breast Cancer
Conditions
Keywords
Advanced Solid Tumors, NSCLC, Head and Neck Cancer
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
Interventions
DRUGTUB-030
A complete treatment cycle is defined as 21 calendar days. TUB-030 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
Sponsors
Tubulis GmbH
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. 12. Males must use an effective barrier method of contraception without interruption if the patient is sexually active with an WOCBP until the end of exposure, 5 half-lives plus 6 months add-on after the end of treatment. In addition, their female partners who are WOCBP should agree to use 1 highly effective barrier method of contraception at the same time. Male patients should refrain from donating sperm during study participation and for 6 months after the last dose of the study drug.
Exclusion criteria
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Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada, France, Romania, Spain, United States
Contacts
CONTACTTubulis Clinical Trial Inquiries
STUDY_DIRECTORYariv Houvras, MD, PhD
Tubulis GmbH
Outcome results
None listed