Advanced Solid TumorsPhase 1/2NCT06657222
First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing TUB-030 in people with Advanced Solid Tumors and HNSCC, run by Gilead Sciences at 20 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, HNSCC, SCLC
- What is being tested?
- TUB-030
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 13 Dec 2024to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-breastfeeding female aged 18 years or older
- Adequate organ function
- 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
- AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.
- For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.
- 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.
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- 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.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Have a life expectancy of >12 weeks for disease-related mortality, as evaluated by the INV.
- In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent
- 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.
- 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.
Who cannot join
- -
Trial locations and contacts
20 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 5 countries
United States13 sites, 13 recruiting
- Recruiting
NEXT Oncology Austin
Austin, Texas, 78758
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Ohio State University
Columbus, Ohio, 43210
- Recruiting
NEXT Oncology - Dallas
Irving, Texas, 75039
- Recruiting
University of Miami
Miami, Florida, 33136
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06510
- Recruiting
Mount Sinai
New York, New York, 11766
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
NEXT Oncology - San Antonio
San Antonio, Texas, 78229
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Recruiting
Washington University
St Louis, Missouri, 63130
France2 sites, 2 recruiting
- Recruiting
Institut Curie
Paris, 75005
- Not yet recruiting
Institut Gustave Roussy
Villejuif, 94805
Romania2 sites, 2 recruiting
- Recruiting
Arensia Exploratory Medicine
Bucharest
- Recruiting
Arensia Exploratory Medicine
Cluj-Napoca
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clinic Barcelona
Barcelona
- Recruiting
Clinica Uni de Navara
Madrid
About this study
Official title: A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)
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.
Read more
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
- Conditions
- Advanced Solid Tumors, HNSCC, SCLC, NSCLC, TNBC - Triple-Negative Breast Cancer, CRC
- Being tested
- TUB-030
- Keywords
- Advanced Solid Tumors, NSCLC, Head and Neck Cancer
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUB-030Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: dose escalation | Experimental | Drug TUB-030, administered by intravenous (IV) infusion Receives: Drug: TUB-030 |
| Phase 2: dose optimization in NSCLC and HNSCC | Experimental | 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 Receives: Drug: TUB-030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of MTD
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
Measured: From enrollment until 30 days after last study drug
Secondary outcomes (8)
Number of patients with Adverse Events (AE)
Any medical event in a participant which may or may not have a causal relationship with this treatment.
Measured: From enrollment until 30 days after last study drug
Maximum concentration (Cmax)
The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
Measured: From enrollment until 30 days after last study drug
Trough concentration (Cmin)
The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Cmin will be derived).
Measured: From enrollment until 30 days after last study drug
The time taken to reach the maximum concentration (Tmax)
The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Tmax will be derived).
Measured: From enrollment until 30 days after last study drug
Area Under Curve (AUC)
PK endpoint
Measured: From enrollment until 30 days after last study drug
Half life (T1/2)
PK endpoint
Measured: From enrollment until 30 days after last study drug
Determination of immunogenicity
Number and percentage of patients developing anti-TUB-030 antibodies
Measured: From enrollment until 30 days after last study drug
Determination of efficacy
ORR by investigator assest Recist 1.1
Measured: From enrolment until 30 days after last study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start13 Dec 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yariv Houvras, MD, PhD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657222
- Sponsor's protocol ID
- 5-STAR 1-01
- Status last verified
- Sep 2026
- First submitted
- 15 Oct 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)
- ClinicalTrials.gov ID
- NCT06657222
- Acronym / sponsor ID
- 5-STAR 1-01
- Conditions
- Advanced Solid Tumors, HNSCC, SCLC, NSCLC, TNBC - Triple-Negative Breast Cancer, CRC
- Keywords
- Advanced Solid Tumors, NSCLC, Head and Neck Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1: dose escalation | Experimental | Drug: TUB-030Drug TUB-030, administered by intravenous (IV) infusion |
| Phase 2: dose optimization in NSCLC and HNSCC | Experimental | Drug: TUB-030Drug 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or non-pregnant, non-breastfeeding female aged 18 years or older
- Adequate organ function
- 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
- AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.
- For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TUB-030A 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 | Drug | Phase 1: dose escalation, Phase 2: dose optimization in NSCLC and HNSCC |
Primary outcome
Determination of MTD
Time frame: 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
8 secondary outcomes
Number of patients with Adverse Events (AE)
Time frame: From enrollment until 30 days after last study drug
Maximum concentration (Cmax)
Time frame: From enrollment until 30 days after last study drug
Trough concentration (Cmin)
Time frame: From enrollment until 30 days after last study drug
The time taken to reach the maximum concentration (Tmax)
Time frame: From enrollment until 30 days after last study drug
Area Under Curve (AUC)
Time frame: From enrollment until 30 days after last study drug
Half life (T1/2)
Time frame: From enrollment until 30 days after last study drug
Determination of immunogenicity
Time frame: From enrollment until 30 days after last study drug
Determination of efficacy
Time frame: From enrolment until 30 days after last study drug.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yariv Houvras, MD, PhD study director
Gilead Sciences
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TUB-030 in people with Advanced Solid Tumors and HNSCC, run by Gilead Sciences at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, France, Romania, Spain, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tubulis Clinical Trial Inquiries (+491758005594, ct-inquiries@tubulis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of MTD (time frame: From enrollment until 30 days after last study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.