What side effects are associated with this type of intervention?

Common treatments for advanced solid tumors, including chemotherapy, targeted therapy, and immunotherapy, often result in a range of side effects. Hematologic toxicities such as neutropenia, anemia, and thrombocytopenia are frequent, leading to increased infection risk and fatigue. Non-hematologic side effects can include nausea, vomiting, diarrhea, and fatigue. Targeted therapies may also cause specific organ toxicities, such as liver dysfunction or cardiotoxicity, while immunotherapies can lead to immune-related adverse events like pneumonitis, colitis, and dermatitis. Monitoring and managing these side effects are crucial for maintaining patient quality of life and treatment efficacy.

What prior FDA approvals exist?

The FDA has approved several treatments for advanced solid tumors, particularly focusing on novel agents and immunotherapies. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are immune checkpoint inhibitors that have been approved for various solid tumors, including non-small cell lung cancer (NSCLC) and melanoma. Atezolizumab (Tecentriq) is another checkpoint inhibitor approved for NSCLC and urothelial carcinoma. Additionally, cabozantinib (Cabometyx) is a tyrosine kinase inhibitor approved for medullary thyroid cancer and renal cell carcinoma. These treatments, like DB-1310, target advanced stages of cancer and aim to improve survival and disease progression outcomes.

What other types of research exist?

Promising alternatives to DB-1310 for advanced solid tumors include: 1) Pembrolizumab (Keytruda) combined with chemotherapy, as seen in the KEYNOTE-189 trial for non-small cell lung cancer. 2) Atezolizumab (Tecentriq) in combination with bevacizumab and chemotherapy, as demonstrated in the IMpower150 trial for non-small cell lung cancer. 3) Cabozantinib (Cabometyx), a tyrosine kinase inhibitor, which has shown efficacy in medullary thyroid cancer and renal cell carcinoma. 4) Nivolumab (Opdivo) combined with ipilimumab (Yervoy), which has been effective in various solid tumors including renal cell carcinoma and melanoma. These therapies have shown significant clinical benefits and are likely to be relevant treatment options in 2024.

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DB-1310 for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by DualityBio Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to follow-up period, approximately 1 year post-treatment

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Specific side effects are not listed but generally, participants may experience issues related to drug tolerance including reactions at the infusion site, fatigue, digestive problems, changes in blood counts or chemistry that reflect organ function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to follow-up period, approximately 1 year post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to follow-up period, approximately 1 year post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to follow-up period, approximately 1 year post-treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose (MTD) of DB-1310

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs

Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

+5 more

Secondary study objectives

Phase 1 & Phase 2a: Pharmacokinetic-AUC

Phase 1 & Phase 2a: Pharmacokinetic-Cmax

Phase 1 & Phase 2a: Pharmacokinetic-T1/2

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

22Treatment groups

Experimental Treatment

Group I: DB-1310 Dose Level 9Experimental Treatment2 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 II: DB-1310 Dose Level 8Experimental Treatment2 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 7Experimental Treatment2 Interventions

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

Group IV: DB-1310 Dose Level 6Experimental Treatment2 Interventions

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

Group V: DB-1310 Dose Level 5Experimental Treatment1 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 4Experimental Treatment1 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 3Experimental Treatment1 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 2Experimental Treatment1 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 11Experimental Treatment2 Interventions

Group X: DB-1310 Dose Level 10Experimental Treatment2 Interventions

Group XI: DB-1310 Dose Level 1Experimental Treatment1 Intervention

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

Group XII: DB-1310 Dose Expansion 9Experimental Treatment1 Intervention

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

Group XIII: DB-1310 Dose Expansion 8Experimental Treatment2 Interventions

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

Group XIV: DB-1310 Dose Expansion 7Experimental Treatment2 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 XV: DB-1310 Dose Expansion 6Experimental Treatment1 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 XVI: DB-1310 Dose Expansion 5Experimental Treatment2 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 XVII: DB-1310 Dose Expansion 4Experimental Treatment1 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 XVIII: DB-1310 Dose Expansion 3Experimental Treatment1 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 XIX: DB-1310 Dose Expansion 2Experimental Treatment1 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 XX: DB-1310 Dose Expansion 11Experimental Treatment1 Intervention

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

Group XXI: DB-1310 Dose Expansion 10Experimental Treatment1 Intervention

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

Group XXII: DB-1310 Dose Expansion 1Experimental Treatment1 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osimertinib

2017

Completed Phase 4

~1120

Trastuzumab

2014

Completed Phase 4

~5190

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular pathways crucial for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy, including checkpoint inhibitors like pembrolizumab, enhances the body's immune response against cancer cells. The novel agent DB-1310, being studied for advanced solid tumors, likely falls into one of these categories, potentially offering a new mechanism to inhibit tumor growth or enhance immune response. Understanding these mechanisms is crucial for patients as it informs treatment choices and potential side effects, ultimately aiming to improve survival and quality of life.