BridgeMD
New treatment option for Solid Tumor
Official title A Phase 1 Study of BHV-1530 in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06874335
What this study is testing
What is BHV-1530?
BHV-1530 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Also referred to as AMB302.
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 Phase 1, first in human (FIH), Open-Label, Dose Escalation, Dose Expansion and Dose Optimization Study of BHV-1530 as Monotherapy and in Combination with Other Anti-Cancer Agents in Adult Participants with Advanced or Metastatic Solid Tumors
- Phase 1: an early, usually small safety study
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
- Signed, written Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved informed consent
- Age greater than or equal to 18 years
- Participants consent to provide tumor tissue collected prior to study treatment, preferably from a biopsy performed after their last anticancer...
- Participants must have progressed following, are intolerant of, or have no available standard-of-care therapy.
- Patients with histologically or cytologically confirmed locally advanced/metastatic relapsed or refractory solid tumors as outlined below:
You likely can't join if
- Prior treatment with antibody drug conjugate (ADC) with a topoisomerase-I inhibitor payload. Prior direct treatment with topoisomerase inhibitor...
- Participant has clinically significant intercurrent disease including, but not limited to:
- New York Heart Association Class III or IV heart failure
- Myocardial infarction, unstable angina, or stroke ≤ 6 months prior to C1D1
- Newly diagnosed thromboembolic events that require therapeutic intervention over the last 4 months prior to C1D1 (participants with stable control of...
- Severe aortic stenosis
See the full eligibility criteria
Who can join
- Signed, written Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved informed consent
- Age greater than or equal to 18 years
- Participants consent to provide tumor tissue collected prior to study treatment, preferably from a biopsy performed after their last anticancer therapy and within 90 days of the start of study treatment. An older...
- Participants must have progressed following, are intolerant of, or have no available standard-of-care therapy.
- Patients with histologically or cytologically confirmed locally advanced/metastatic relapsed or refractory solid tumors as outlined below:
- Dose Escalation and Dose Expansion (Backfill) Cohorts (BHV-1530 monotherapy):
- Participants with urothelial cancer of the urinary tract: (including renal pelvis, ureters, urinary bladder, and urethra), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) of the oral...
- Tumors originating from the salivary glands, or unknown primary sites are not eligible.
- Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation or fusion).
- Dose Escalation and Dose Expansion (Backfill) Cohorts (BHV-1530 in combination with cemiplimab):
- Participants with urothelial cancer of the urinary tract: (including renal pelvis, ureters, urinary bladder, and urethra), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) of the oral...
- Tumors originating from the salivary glands, or unknown primary sites are not eligible.
- Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation or fusion). Participants must have received ≤ 2 prior lines of systemic anti-cancer therapy which may include at most one...
- Measurable advanced or metastatic tumors per RECIST 1.1 criteria
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Acceptable liver function:
- Bilirubin ≤ 1.5 × upper limit of normal (ULN). Participants with known Gilbert's syndrome who have total bilirubin level ≤3×ULN may be enrolled.
- AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN (if liver metastases are present, then ≤ 5 × ULN is allowed)
- Acceptable renal function:
- Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min as calculated using the modified Cockcroft-Gault equation; confirmation of creatinine clearance is only required when creatinine is \>1.5 × ULN; 24-hour...
- Acceptable hematologic status:
- Blood transfusion or growth factor support is not allowed within 7 days prior to blood samples that will be used to establish eligibility
- Absolute neutrophil count greater than or equal to 1500/mm3. Participants with known Duffy null phenotype who have absolute neutrophil count ≥ 1,200/mm3 may be enrolled
- Platelet count greater than or equal to 100,000 mm3
- Hemoglobin greater than or equal to 9 g/dL
- Activated partial thromboplastin time (aPTT) ≤1.5×ULN. Study participants on therapeutic doses of anticoagulation medication must have INR and/or aPTT ≤ the upper limit of the therapeutic range for intended use
- A negative urine or serum pregnancy test (if a woman of childbearing potential);
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 7 months (for women) or 4 months (for men) after the last dose of...
What rules you out
- Prior treatment with antibody drug conjugate (ADC) with a topoisomerase-I inhibitor payload. Prior direct treatment with topoisomerase inhibitor (e.g., irinotecan, topotecan, belotecan, nano-liposomal irinotecan) are...
- Participant has clinically significant intercurrent disease including, but not limited to:
- New York Heart Association Class III or IV heart failure
- Myocardial infarction, unstable angina, or stroke ≤ 6 months prior to C1D1
- Newly diagnosed thromboembolic events that require therapeutic intervention over the last 4 months prior to C1D1 (participants with stable control of lower limb deep venous thrombosis over at least 1 months are allowed...
- Severe aortic stenosis
- Uncontrolled arrhythmia
- Symptomatic pericardial effusion
- Congenital long QT syndrome
- A mean of Fredericia's formula-QT corrected interval (QTcF) prolongation to \>470 msec based on a triplicate 12-lead ECG
- Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg) or diabetes (hemoglobin A1C ≥9.0%)
- Left ventricular ejection fraction (LVEF) \<45% determined by echocardiogram or multiple gated acquisition scan (MUGA)
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Primary central nervous system (CNS) tumors, current or previously treated leptomeningeal disease or known active brain metastases. NOTE: Participants with previously treated, clinically stable, radiologically stable...
- Pregnant or nursing women
- Any standard cancer therapy (e.g., chemotherapy, hormonal therapy, radiotherapy, immunotherapy, biologic therapy treatment) or experimental therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to C1D1...
- Participants have not recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo. If the participant has an ongoing, stable, chronic Grade 2...
- Any clinically significant corneal or retinal abnormality that may increase the risk of eye toxicity
- Known active infection with human immunodeficiency virus (HIV), human T-cell leukemia virus, type 1 (HTLV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV), if allowed by local regulations:
- Participants with hepatitis B (hepatitis B virus surface antigen [HbsAg] positive), or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV ribonucleic acid). Participants with HCV with undetectable...
- Participants with human immunodeficiency virus (HIV) infection with acquired immune deficiency syndrome (AIDS) defining illness are not eligible for enrollment; however, participants who have had HIV infection and who...
- Has an active second malignancy. Note: participants with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or participants with tumors cured...
- Participants who in the opinion of the Investigator will not be able to adhere to the schedule of assessments and/or may have difficulties complying with the treatment regimen or are unwilling or unable to comply with...
- Known sensitivity to BHV-1530 or any of the excipients in BHV-1530;
- History of (noninfectious) clinically significant interstitial lung disease (ILD)/pneumonitis that required steroids, active clinically significant ILD/pneumonitis, or suspected clinically significant ILD/pneumonitis...
- Requires supplemental oxygen for daily activities
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
- Combination Specific Exclusion Criteria: To be eligible to participate in the combination arms of the study, participants must not meet the combination specific exclusion criteria in addition to the general exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- Denver, Colorado, United States
- Lake Mary, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
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 Newport Beach, California, United States; Denver, Colorado, United States; Lake Mary, Florida, United States; Miami, Florida, United States; Orlando, Florida, United States; Ann Arbor, Michigan, United States and 11 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.