BridgeMD
New treatment option for Advanced Solid Tumor
Official title A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06172478
What this study is testing
What is HER3-DXd?
HER3-DXd is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Also referred to as Patritumab Deruxtecan, U3-1402.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma [cutaneous/acral], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must meet all of the following criteria to be eligible for enrollment into the study:
- Sign and date the informed consent form prior to the start of any study-specific qualification procedures. A separate tissue screening consent will...
- Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years old).
- Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows: Cutaneous (acral and non-acral) melanoma
- Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma
You likely can't join if
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is...
- Has nasopharyngeal cancer.
- Has mucosal or uveal melanoma.
- Has a history of (non-infectious) interstitial lung disease (ILD), that required corticosteroids, has current ILD/pneumonitis, or suspected...
- Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
See the full eligibility criteria
Who can join
- Participants must meet all of the following criteria to be eligible for enrollment into the study:
- Sign and date the informed consent form prior to the start of any study-specific qualification procedures. A separate tissue screening consent will be obtained from all people to meet the baseline tumor tissue...
- Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years old).
- Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows: Cutaneous (acral and non-acral) melanoma
- Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma
- Disease progression while on or after having received treatment with ≥1 prior line of anti-programmed cell death protein (PD-1) or anti-programmed death-ligand 1 (PD-L1) based therapy (previous use of other immune...
- Squamous cell carcinoma of the head and neck (with a primary location of oral cavity,oropharynx, larynx, hypopharynx) that is human papillomavirus (HPV) positive or negative (as determined by local standard). Excludes...
- Disease progression after having received treatment with ≥1 and \<3 prior lines of systemic therapy in the unresectable recurrent or metastatic setting. Must have had disease progression on anti-PD-(L)1 (either as...
- Tumor tissue must be confirmed as negative for HER2 expression (immunohistochemistry [IHC] 0/1+ or IHC 2+/in situ hybridization negative) as classified by American Society of Clinical Oncology/College of American...
- Disease progression after having received treatment with ≥2 prior lines of therapy that include PBC with or without anti-PD-1 therapy. Ovarian Carcinoma
- Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Documented disease progression ≥4 weeks after the last dose of PBC and \<6 months of last dose of PBC in the advanced or metastatic setting. Prior use of folate reductase alpha targeting antibody-drug conjugate (ADC)...
- Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.
- Disease progression after having received ≥1 line of systemic therapy in the recurrent or metastatic setting. This may include prior anti-PD-(L)1 treatment and/or tissue factor directed ADC (tisotumab vedotin [TV]) per...
- Pathologically or cytologically documented endometrial cancer (carcinoma of any histological sub-type or endometrial carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair (MMR) status.
- Documented disease progression after having received ≥1 prior line of therapy (maximum of 3) PBC containing systemic treatment and an anti-PD(L)-1 therapy-containing regimen (combined or sequential) in the...
- Pathologically or cytologically documented locally advanced/unresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is...
- Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting. At least 1 line of therapy must also contain one of the...
- Required treatments can be given in combination or sequentially
- Prior cisplatin-based therapy or PD-(L)1 inhibitor therapy given for the treatment of muscle invasive urothelial carcinoma is counted as 1 line of therapy
- The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy
- Participants in the second-line setting who have previously received enfortumab vedotin and pembrolizumab in combination can be enrolled. Esophageal Carcinoma
- Pathologically or cytologically documented esophageal squamous cell carcinoma.
- Must have documented disease progression after having received 2 prior lines of therapy including previous PBC with or without an anti-PD-1 therapy-containing regimen (combined or sequential) in the advanced/metastatic...
- Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.
- Relapsed or disease progression after having received 1 prior line of systemic therapy in the locally advanced/metastatic setting. Prostate Cancer
- Pathologically or cytologically documented unresectable locally advanced or metastatic castration-resistant prostate cancer (CRPC).
- Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
- Surgically or medically castrated, with testosterone levels of \<50 ng/dL.
- Documented objective progression as determined by radiographic progression for people with measurable disease after androgen deprivation.
- Relapsed or disease progression after having received treatment with ≥1 of the following novel hormonal agents: abiraterone, enzalutamide, apalutamide, or darolutamide.
- Relapsed or disease progression after having received ≥1 cytotoxic chemotherapy regimen that included a taxane. Gastric Cancer 2L
- Must have had gastric or GEJ adenocarcinoma confirmed as negative for HER2 expression (IHC 0/1+ or IHC 2+/in situ hybridization negative) as classified by American Society of Clinical Oncology/College of American...
- Disease progression after having received treatment with only 1 prior line of systemic anti-cancer therapy that includes 5-FU-based chemotherapy with or without an anti-PD-1 therapy. For people whose tumors are claudin...
- Has ≥1 measurable lesion on CT or MRI as per RECIST v1.1 by investigator assessment. Prostate cancer participants with bone only disease may be eligible.
- Provides a pretreatment tumor tissue sample that meets 1 of the following collection requirements:
- Tumor biopsy from ≥1 lesion not previously irradiated and performed since progression with the most recent systemic cancer therapy regimen and prior to signature of the tissue ICF (ARCHIVAL PRETREATMENT sample). OR
- Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of tissue ICF (FRESH PRETREATMENT sample)
- Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.
What rules you out
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or...
- Has nasopharyngeal cancer.
- Has mucosal or uveal melanoma.
- Has a history of (non-infectious) interstitial lung disease (ILD), that required corticosteroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
- Is receiving chronic systemic corticosteroids dosed at \>10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Participants who require use of...
- Had prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan).
- Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following:
- Adequately treated nonmelanoma skin cancer
- Adequately treated intraepithelial carcinoma of the cervix
- Any other curatively treated in situ disease
- Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active serious infection) psychiatric illness/social situations, geographical factors, substance abuse, or other factors that, in the...
- Has previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- New Haven, Connecticut, United States
- Kissimmee, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Saint Louis Park, Minnesota, United States
- Saint Paul, Minnesota, United States
- St Louis, Missouri, United States
- Buffalo, New York, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Camperdown, Australia
- Chermside, Australia
- Clayton, Australia
- Hobart, Australia
- Hyde Park, Australia
- Brussels, Belgium
- Edegem, Belgium
+ 52 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; New Haven, Connecticut, United States; Kissimmee, Florida, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States; Saint Louis Park, Minnesota, United States and 66 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.