DB-1305 for Solid Tumors

Recruiting at 2 trial locations

Overseen By Cathy Li

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 1 & 2

Sponsor: DualityBio Inc.

Disqualifiers: Heart failure, Myocardial infarction, ILD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

902 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called DB-1305 to see if it is safe for patients with advanced solid tumors that are hard to treat. The study will begin with smaller amounts of the drug and increase them over time to find the safest and most effective dose.

Will I have to stop taking my current medications?

The trial requires an adequate treatment washout period (time without taking certain medications) before starting the study, which suggests you may need to stop some current medications. However, the specific medications that need to be stopped are not detailed in the provided information.

What data supports the effectiveness of the drug DB-1305 for solid tumors?

The research shows that similar drugs, like vinorelbine and cisplatin, have been effective in treating advanced non-small cell lung cancer, suggesting that combination therapies can be beneficial for solid tumors. ^{1 2 3 4 5}

Who Is on the Research Team?

Lily Hu

Principal Investigator

DualityBio Inc.

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that have worsened after standard treatments or when no standard treatment exists. Participants must be willing to provide tumor samples, have a life expectancy of at least 3 months, be in good physical condition (ECOG 0-1), and have proper organ function.

Inclusion Criteria

Do you have one of the following types of cancer?: Mesothelioma, Non-Small Cell Lung Cancer, Cervical Cancer, Endometrial Cancer, or Breast Cancer?

Is your cancer HER2 positive?

Would you be willing to provide a pre-existing tumor sample or undergo a biopsy?

Exclusion Criteria

Have you had a medical history of symptomatic congestive heart failure (CHF), interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases?

Do you currently have an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals, or do you currently have or have had human immunodeficiency virus (HIV) infection with acquired immune deficiency syndrome (AIDS) defining illness?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1 adopts an accelerated titration at first dose level followed with classic '3+3' design to identify the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D)

Approximately 12 months

Dose Expansion

Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D

Approximately 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days after last study treatment administration

What Are the Treatments Tested in This Trial?

Interventions

• DB-1305

Trial Overview DB-1305 is being tested for safety and effectiveness in treating advanced solid tumors. This early-phase trial gradually increases the dose to find the right balance between benefits and side effects before expanding to more patients.

How Is the Trial Designed?

Group I: Experimental: DB-1305/BNT325 in combination with BNT327 Experimental Treatment 2 Interventions

Enrolled subjects will receive DB-1305/BNT325 in combination with BNT327

Group II: Experimental: DB-1305/BNT325 Dose Level 8 Experimental Treatment 1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 8

Group III: Experimental: DB-1305/BNT325 Dose Expansion PM5 Experimental Treatment 2 Interventions

Enrolled subjects with TNBC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327

Group IV: Experimental: DB-1305/BNT325 Dose Expansion PM4 Experimental Treatment 2 Interventions

Enrolled subjects with OC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327

Group V: Experimental: DB-1305/BNT325 Dose Expansion PM3 Experimental Treatment 2 Interventions

Enrolled subjects with CC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327

Group VI: Experimental: DB-1305/BNT325 Dose Expansion PM2 Experimental Treatment 2 Interventions

Enrolled subjects with NSCLC with AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327

Group VII: Experimental: DB-1305/BNT325 Dose Expansion PM1 Experimental Treatment 2 Interventions

Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327

Group VIII: Experimental: DB-1305/BNT325 Dose Expansion 10 Experimental Treatment 1 Intervention

Enrolled subjects with pancreatic cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group IX: DB-1305/BNT325 in combination with pembrolizumab Experimental Treatment 2 Interventions

Enrolled subjects will receive DB-1305/BNT325 in combination with pembrolizumab

Group X: DB-1305/BNT325 Dose Level 7 Experimental Treatment 1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 7

Group XI: DB-1305/BNT325 Dose Level 6 Experimental Treatment 1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 6

Group XII: DB-1305/BNT325 Dose Level 5 Experimental Treatment 1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 5

Group XIII: DB-1305/BNT325 Dose Level 4 Experimental Treatment 1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 4

Group XIV: DB-1305/BNT325 Dose Level 3 Experimental Treatment 1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 3

Group XV: DB-1305/BNT325 Dose Level 2 Experimental Treatment 1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 2

Group XVI: DB-1305/BNT325 Dose Level 1 Experimental Treatment 1 Intervention

Enrolled subjects will receive DB-1305/BNT325 at Dose Level 1

Group XVII: DB-1305/BNT325 Dose Expansion PB1 Experimental Treatment 2 Interventions

Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with pembrolizumab

Group XVIII: DB-1305/BNT325 Dose Expansion 9 Experimental Treatment 1 Intervention

Enrolled subjects with Cervical Cancer (CC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XIX: DB-1305/BNT325 Dose Expansion 8 Experimental Treatment 1 Intervention

Enrolled subjects with malignant mesothelioma will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XX: DB-1305/BNT325 Dose Expansion 7 Experimental Treatment 1 Intervention

Enrolled subjects with EC who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XXI: DB-1305/BNT325 Dose Expansion 6 Experimental Treatment 1 Intervention

Enrolled subjects with TNBC with treatment failure on sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XXII: DB-1305/BNT325 Dose Expansion 5 Experimental Treatment 1 Intervention

Enrolled subjects with Triple-Negative Breast Cancer (TNBC) who have progressed on or after standard systemic treatments and without prior treatment of sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XXIII: DB-1305/BNT325 Dose Expansion 4 Experimental Treatment 1 Intervention

Enrolled subjects with BC who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XXIV: DB-1305/BNT325 Dose Expansion 3 Experimental Treatment 1 Intervention

Enrolled subjects with OC who will receive DB-1305/BNT325 on either dose level 1 or dose level 2

Group XXV: DB-1305/BNT325 Dose Expansion 2 Experimental Treatment 1 Intervention

Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on either dose level 1 or dose level 2

Group XXVI: DB-1305/BNT325 Dose Expansion 12 Experimental Treatment 1 Intervention

Enrolled subjects with head and neck cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XXVII: DB-1305/BNT325 Dose Expansion 11 Experimental Treatment 1 Intervention

Enrolled subjects with Castration-Resistant Prostate Cancer (CRPC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)

Group XXVIII: DB-1305/BNT325 Dose Expansion 1 Experimental Treatment 1 Intervention

subjects with Non-Small Cell Lung Cancer (NSCLC) with actionable genetic alterations (AGAs) who will receive DB-1305/BNT325 on either dose level 1 or dose level 2

DB-1305 is already approved in United States for the following indications:

Approved in United States as BNT325/DB-1305 for:

• Platinum-resistant ovarian epithelial cancer
• Fallopian tube cancer
• Primary peritoneal cancer

Who Is Running the Clinical Trial?

DualityBio Inc.

Lead Sponsor

Trials

12

Recruited

5,800+

BioNTech SE

Industry Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Published Research Related to This Trial

In a phase I study involving 38 patients with refractory solid tumors, the maximum tolerated doses (MTD) for vinorelbine and oxaliplatin were determined to be 27 mg/m2 and 50 mg/m2, respectively, with notable dose-limiting toxicities including grade 4 neutropenia.

The combination treatment showed some efficacy, with 4% achieving complete response and 20% partial response, particularly in patients with ovarian and breast cancer, suggesting potential for further evaluation in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A dose-escalation study of oxaliplatin and vinorelbine in patients with advanced solid tumors. Kakolyris, S., Kouroussis, C., Koukourakis, M., et al.[2018]

Vinorelbine combined with cisplatin shows an overall response rate of 30.9% in treating inoperable non-small cell lung cancer (NSCLC), with a median survival duration of 8.3 months based on a study of 220 patients.

The treatment is generally well-tolerated, although the main side effects include myelosuppression and digestive tract reactions, with myelosuppression identified as the dose-limiting toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical research on combined chemotherapy of vinorelbine and cisplatin in the treatment of non-small cell lung cancer]. Xu, L., Zhu, Y., You, Y., et al.[2011]

The combination chemotherapy of NVB and DDP showed a 53.8% overall response rate in 52 patients with advanced non-small cell lung cancer, indicating its effectiveness as a treatment option.

The main side effects included leucopenia, nausea, vomiting, and phlebitis, but these were generally well tolerated, suggesting that the NP regimen can be considered a viable first-line treatment for this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[NVB and DDP combination chemotherapy in the treatment of advanced non-small cell lung cancer]. Jiang, H., Fan, Y., Yu, D.[2011]

Technological advances in cancer research are revealing new therapeutic targets and enhancing our understanding of tumors, but therapy resistance remains a significant challenge for advanced cancers, limiting the effectiveness of single-agent treatments.

With around 5,000 clinical trials exploring combination therapies, there is a need for more rational design of these combinations based on biological insights to avoid issues like missed opportunities and clinical failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rational Cancer Treatment Combinations: An Urgent Clinical Need. Boshuizen, J., Peeper, DS.[2020]

Combination chemotherapy using navelbine (NVB) and cisplatin (DDP) resulted in a 47.8% overall response rate in 46 patients with advanced non-small cell lung cancer (NSCLC), with a median survival time of 9.5 months and a one-year survival rate of 39.1%.

The treatment was associated with manageable toxicities, primarily myelosuppression and nausea/vomiting, indicating that while side effects occurred, they were tolerable for patients undergoing this regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study of navelbine combined with cisplatin in the treatment of advanced non-small cell lung cancer]. He, Y.[2011]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

A dose-escalation study of oxaliplatin and vinorelbine in patients with advanced solid tumors. [2018]

2. China pubmed.ncbi.nlm.nih.gov

[Clinical research on combined chemotherapy of vinorelbine and cisplatin in the treatment of non-small cell lung cancer]. [2011]

3. China pubmed.ncbi.nlm.nih.gov

[NVB and DDP combination chemotherapy in the treatment of advanced non-small cell lung cancer]. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Rational Cancer Treatment Combinations: An Urgent Clinical Need. [2020]

5. China pubmed.ncbi.nlm.nih.gov

[Clinical study of navelbine combined with cisplatin in the treatment of advanced non-small cell lung cancer]. [2011]