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HNSCC / TUB-030 / SCLC · Phase 1/2 Trial
ClinicalTrials.gov · September 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a first-in-human Phase 1/2 registration for TUB-030, a novel investigational drug in patients with advanced solid tumors including head and neck cancer, small-cell lung cancer, non-small-cell lung cancer, triple-negative breast cancer, and colorectal cancer. The trial aims to establish safety, tolerability, and maximum tolerated dose; no results are reported in this registry record.
Phase 1/2, Interventional, Randomized, Sequential, Open label, Treatment purpose. Advanced Solid Tumors, HNSCC, SCLC, NSCLC, TNBC - Triple-Negative Breast Cancer, CRC; age from 18 Years. Intervention: Phase 1: dose escalation; Phase 2: dose optimization in NSCLC and HNSCC. n = 250. 20 sites across 5 countries.
This is a first-in-human Phase 1/2 registration for TUB-030, a novel investigational drug in patients with advanced solid tumors including head and neck cancer, small-cell lung cancer, non-small-cell lung cancer, triple-negative breast cancer, and colorectal cancer. The trial aims to establish safety, tolerability, and maximum tolerated dose; no results are reported in this registry record.
Primary endpoint is safety and MTD determination, not clinical efficacy or survival.
This registry record documents study initiation and design only. Clinical professionals should await publication of results before drawing conclusions about TUB-030 safety, tolerability, or efficacy in any population.
First-in-human Phase 1/2 trial of a novel agent in early-stage development; no results posted; designed to establish safety, tolerability, and maximum tolerated dose rather than efficacy.
As stated by the source record.
Quoted from the source exactly as published.
This registry record documents study initiation and design only. Clinical professionals should await publication of results before drawing conclusions about TUB-030 safety, tolerability, or efficacy in any population.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06657222). This is a study registration, not published results. Lead sponsor: Tubulis GmbH. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 250 participants (ESTIMATED). Conditions: Advanced Solid Tumors, HNSCC, SCLC, NSCLC, TNBC - Triple-Negative Breast Cancer, CRC. Interventions: DRUG: TUB-030. Primary outcome measures: Determination of MTD , From enrollment until 30 days after last study drug. 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
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.