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Cancer Vaccine

TUB-030 for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Tubulis GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or non-pregnant, non-breastfeeding female aged 18 years or older

For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrolment until 30 days after last study drug.

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if the drug TUB-030 is effective in treating solid cancer in adults and to assess its safety. They will determine the best dose of TUB-030 for patients with

Who is the study for?

This trial is for adults with advanced solid tumors, including specific cancers like breast cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and small cell lung cancer. Participants must be able to visit the clinic every three weeks and complete questionnaires about their symptoms.

What is being tested?

The drug TUB-030 is being tested for its effectiveness in treating various solid tumors. The study will determine the safest high dose of TUB-030 when given alone. It will also assess how well it works specifically on head and neck as well as non-small cell lung cancers.

What are the potential side effects?

While not specified here, common side effects from new cancer drugs can include nausea, fatigue, allergic reactions or skin rashes. Safety checks at clinic visits help monitor any adverse effects participants may experience.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult over 18 and not pregnant or breastfeeding.

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My brain cancer has not worsened after radiation therapy.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment until 30 days after last study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment until 30 days after last study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until 30 days after last study drug for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determination of MTD

Secondary study objectives

Area Under Curve (AUC)

Determination of efficacy

Determination of immunogenicity

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2: dose optimization in NSCLC and HNSCCExperimental Treatment1 Intervention

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

Group II: Phase 1: dose escalationExperimental Treatment1 Intervention

Drug TUB-030, administered by intravenous (IV) infusion

0 / 3Eligibility criteria met