DB-1310 for Advanced Cancer

Recruiting at 24 trial locations

Overseen By Tiana Zhao

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: DualityBio Inc.

Must not be taking: HER3 therapies, CYP3A4 inducers

Disqualifiers: Heart failure, Myocardial infarction, ILD, others

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

Compensation: Varies

Number of Visits: Unknown

1000 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-1310 to see if it is safe for patients with advanced solid tumors. It will also check if combining DB-1310 with another drug, trastuzumab, helps fight cancer better.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you may need to avoid certain drugs that affect the heart's rhythm or those that interact with specific enzymes (CYP3A4). It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug DB-1310 for advanced cancer?

The research mentions capecitabine, a component of DB-1310, as an effective treatment for advanced breast cancer, showing response rates of 20-36% in various studies. This suggests potential effectiveness of DB-1310 in treating advanced cancer. ^{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 (≥18 years) with advanced solid tumors who've tried standard treatments without success or can't tolerate them. They must have a life expectancy of ≥3 months, good organ function, and an ECOG performance status of 0-1. Participants need measurable lesions per RECIST criteria or qualify for Phase 2a Cohort 2c. Women shouldn't be pregnant/breastfeeding and along with men, must use contraception.

Inclusion Criteria

I understand the study's procedures and risks, can consent in writing, and will follow the study requirements.

I agree not to freeze or donate sperm during and for 4 months after the study.

I have at least one tumor that can be measured.

Exclusion Criteria

I have active hepatitis.

I had a heart attack or unstable chest pain in the last 6 months.

Know human immunodeficiency virus (HIV) infection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Dose-escalation phase to identify the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of DB-1310 as monotherapy and in combination with other drugs

8 cycles (each cycle is 21 days)

Phase 2a Treatment

Dose-expansion phase to confirm safety, tolerability, and explore efficacy of DB-1310 in selected malignant solid tumors

8 cycles (each cycle is 21 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 1 year post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• DB-1310

Trial Overview DB-1310 is being tested in this Phase 1/2a trial to see how safe it is and how well people with advanced solid tumors can handle different doses. The study will gradually increase the dose (dose-escalation) and then give it to more people at the best dose found (dose-expansion).

How Is the Trial Designed?

Group I: DB-1310 Dose Level 9 Experimental Treatment 2 Interventions

Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab

Group II: DB-1310 Dose Level 8 Experimental Treatment 3 Interventions

Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab

Group III: DB-1310 Dose Level 7 Experimental Treatment 2 Interventions

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W

Group IV: DB-1310 Dose Level 6 Experimental Treatment 2 Interventions

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W

Group V: DB-1310 Dose Level 5 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 5 on Day 1 of each cycle Q3W

Group VI: DB-1310 Dose Level 4 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 4 on Day 1 of each cycle Q3W

Group VII: DB-1310 Dose Level 3 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 3 on Day 1 of each cycle Q3W

Group VIII: DB-1310 Dose Level 2 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 2 on Day 1 of each cycle Q3W

Group IX: DB-1310 Dose Level 13 Experimental Treatment 2 Interventions

Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib

Group X: DB-1310 Dose Level 12 Experimental Treatment 2 Interventions

Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib

Group XI: DB-1310 Dose Level 11 Experimental Treatment 3 Interventions

Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib

Group XII: DB-1310 Dose Level 10 Experimental Treatment 2 Interventions

Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab

Group XIII: DB-1310 Dose Level 1 Experimental Treatment 1 Intervention

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W

Group XIV: DB-1310 Dose Expansion 9 Experimental Treatment 1 Intervention

Enrolled subjects with NSCLC with KRAS mutation who will receive DB-1310 on a selected dose level (RP2D)

Group XV: DB-1310 Dose Expansion 8 Experimental Treatment 2 Interventions

Enrolled subjects with NSCLC with EGFR who will receive DB-1310 on a selected dose level in combination with Osimertinib

Group XVI: DB-1310 Dose Expansion 7 Experimental Treatment 2 Interventions

Enrolled subjects with advanced/unresectable, or metastatic non-squamous NSCLC with EGFR exon 19 deletion or L858R mutation who haven't received any treatment in locally advanced, or metastatic disease will receive a single-dose of DB-1310 on a selected dose level Day 1 of each cycle Q3W in combination with Osimertinib.

Group XVII: DB-1310 Dose Expansion 6 Experimental Treatment 1 Intervention

Enrolled Subject with other advanced/unresectable, or metastatic solid tumors who have progressed on or after standard systemic treatment, or for which no standard systemic treatment is available will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Group XVIII: DB-1310 Dose Expansion 5 Experimental Treatment 2 Interventions

Enrolled Subjects with advanced/unresectable, or metastatic BC with HER2-positive (IHC3+, or IHC2+ and ISH+) who have progressed on or after HER2 targeted systemic treatments will receive a single-dose of DB-1310 on a selected dose level Day 1 of each cycle Q3W in combination with trastuzumab deruxtecan.

Group XIX: DB-1310 Dose Expansion 4 Experimental Treatment 1 Intervention

Enrolled Subjects with advanced/unresectable, or metastatic HNSCC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Group XX: DB-1310 Dose Expansion 3 Experimental Treatment 1 Intervention

Enrolled Subjects with advanced/unresectable, or metastatic CRPC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Group XXI: DB-1310 Dose Expansion 2 Experimental Treatment 1 Intervention

Enrolled Subjects with advanced/unresectable, or metastatic NSCLC without EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Group XXII: DB-1310 Dose Expansion 11 Experimental Treatment 1 Intervention

Enrolled subjects with BTC who will receive DB-1310 on a selected dose level (RP2D)

Group XXIII: DB-1310 Dose Expansion 10 Experimental Treatment 1 Intervention

Enrolled subjects with ESCC who will receive DB-1310 on a selected dose level (RP2D)

Group XXIV: DB-1310 Dose Expansion 1 Experimental Treatment 1 Intervention

Enrolled Subjects with advanced/unresectable, or metastatic adenocarcinoma NSCLC with EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Who Is Running the Clinical Trial?

DualityBio Inc.

Lead Sponsor

Trials

12

Recruited

5,800+

Published Research Related to This Trial

The combination of docetaxel and capecitabine was found to be effective in treating anthracycline-resistant metastatic breast cancer, achieving an overall response rate of 46.9% among 32 patients, with a median time to progression of 5.6 months.

The treatment was generally well-tolerated, although common side effects included myelosuppression and hand-foot syndrome, with 84.4% of patients experiencing neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Docetaxel and capecitabine combination chemotherapy for patients with anthracycline-resistant metastatic breast cancer]. Li, SF., Wang, X., Wang, C., et al.[2018]

Oral chemotherapy options like Xeloda (capecitabine) and oral vinorelbine improve access for patients with metastatic breast cancer, especially when hospital visits are challenging due to financial or logistical reasons.

Combination therapies using taxoids and anthracyclines have increased response rates in first-line treatments, but maintenance regimens with less toxic agents can prolong response duration and improve disease-free survival, making outpatient treatment more feasible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing chemotherapy for patients with advanced breast cancer. Marty, M., Espie, M., Cottu, PH., et al.[2017]

Capecitabine, when used as a monotherapy for advanced breast cancer, showed some antitumor activity but had a significant risk of side effects like hand-foot syndrome and diarrhea, and the evidence supporting its effectiveness is limited due to low-quality studies.

In combination with docetaxel, capecitabine demonstrated superior survival and disease progression outcomes compared to docetaxel alone, and while it appeared to be cost-effective, it was associated with higher rates of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the clinical effectiveness and cost-effectiveness of capecitabine (Xeloda) for locally advanced and/or metastatic breast cancer. Jones, L., Hawkins, N., Westwood, M., et al.[2023]

In a study of 63 patients with relapsed and refractory multiple myeloma, the pomalidomide-dexamethasone regimen showed a 51% overall response rate, with significant survival benefits for responders compared to those who discontinued treatment early.

The regimen was found to have a favorable safety profile, with the most common severe side effects being neutropenia (14%) and infections (25%), and it was cost-effective, providing a life-year gain at an incremental cost of €39,911 compared to dexamethasone alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and cost of pomalidomide in relapsed and refractory multiple myeloma. Gueneau, P., Chretien, ML., Cransac-Miet, A., et al.[2018]

Capecitabine, an oral prodrug of 5-fluorouracil, has shown promising efficacy in treating advanced breast cancer, with a response rate of 20% in a phase II study involving 135 patients previously treated with anthracyclines and taxanes.

The side effects of capecitabine are generally mild, with the most common severe toxicities being diarrhea (8%-11%) and hand-foot syndrome (10%-18%), indicating it has a tolerable safety profile for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capecitabine in breast cancer: current status. Smorenburg, CH., Bontenbal, M., Verweij, J.[2015]

Citations

1. China pubmed.ncbi.nlm.nih.gov

[Docetaxel and capecitabine combination chemotherapy for patients with anthracycline-resistant metastatic breast cancer]. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Optimizing chemotherapy for patients with advanced breast cancer. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Systematic review of the clinical effectiveness and cost-effectiveness of capecitabine (Xeloda) for locally advanced and/or metastatic breast cancer. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and cost of pomalidomide in relapsed and refractory multiple myeloma. [2018]

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

Capecitabine in breast cancer: current status. [2015]