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New treatment option for Advanced/Metastatic Solid Tumors
Official title A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT03526835
What this study is testing
What is MCLA-158?
MCLA-158 is an investigational medicine, being studied as a potential treatment for advanced/metastatic solid tumors.
Also referred to as petosemtamab.
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 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC. The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study.
- 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
- Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy with...
- A baseline fresh tumor sample (FFPE) from a metastatic or primary site (if safe/feasible).
- Amenable for biopsy (if safe/feasible).
- Measurable disease as defined by RECIST version 1.1 by radiologic methods.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You likely can't join if
- Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms...
- Known leptomeningeal involvement.
- Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.
- Any systemic anticancer therapy within 4 weeks or 5 half-lives whichever is shorter of the first dose of study treatment. For cytotoxic agents that...
- Requirement for immunosuppressive medication (e.g. methotrexate, cyclophosphamide)
- Major surgery or radiotherapy within 3 weeks of the first dose of study treatment. Patients who received prior radiotherapy to ≥25% of bone marrow...
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
- A baseline fresh tumor sample (FFPE) from a metastatic or primary site (if safe/feasible).
- Amenable for biopsy (if safe/feasible).
- Measurable disease as defined by RECIST version 1.1 by radiologic methods.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks, as per investigator.
- Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).
- Adequate organ function
- Expansion cohorts: patients with locally advanced unresectable or metastatic disease for the following indications: SINGLE AGENT:
- SECOND-/THIRD-LINE HNSCC PATIENTS (cohort closed to enrolment): patients who have progressed on or after, or are intolerant to, anti-PD-(L)1 therapy and platinum therapy as monotherapy or in combination with other...
- Human papilloma virus (HPV) status determined by p16 immunohistochemistry (IHC) or molecular HPV test for all oropharyngeal tumors should be reported when available.
- The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- 3L+ mCRC (cohort open to enrolment) patients must have:
- No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, and no HER2 (ERBB2) amplification, as detected in plasma by ctDNA NGS central testing performed during screening.
- A microsatellite stable (MSS) tumor. COMBINATION:
- FIRST-LINE HNSCC (cohort closed to enrolment): patients eligible to receive pembrolizumab as first-line monotherapy with tumors expressing programmed cell death protein ligand 1 (PD-L1), combined positive score (CPS)...
- mCRC (cohorts open to enrolment): Patients should have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Patients must be RAS/RAF...
- Cohort to be treated with petosemtamab and FOLFIRI: patients may have received up to 1 prior chemotherapy regimen for the metastatic setting, consisting of 1L fluoropyrimidine-oxaliplatin-based chemotherapy ±...
- Cohort to be treated with petosemtamab and FOLFOX: patients may have received up to 1 prior chemotherapy regimen in the metastatic setting consisting of 1L fluoropyrimidine-irinotecan-based chemotherapy ± bevacizumab.
What rules you out
- Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.
- Known leptomeningeal involvement.
- Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.
- Any systemic anticancer therapy within 4 weeks or 5 half-lives whichever is shorter of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity ( e.g. mitomycin C,nitrosoureas), or...
- Requirement for immunosuppressive medication (e.g. methotrexate, cyclophosphamide)
- Major surgery or radiotherapy within 3 weeks of the first dose of study treatment. Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible, irrespective of when it was received.
- Persistent grade \>1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v4.03 is allowed.
- History of hypersensitivity reaction to any of the excipients of petosemtamab, human proteins or any non-IMP treatment required for this study.
- Uncontrolled hypertension (systolic blood pressure [BP] \> 150 mmHg and/or diastolic BP \> 100 mmHg) with appropriate treatment or unstable angina.
- History of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia).
- History of myocardial infarction within 6 months of study entry.
- History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease for 3...
- Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy.
- Patients with a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of ILD on baseline chest computerized tomography (CT) scan.
- Current serious illness or medical conditions including, but not limited to uncontrolled active infection,clinically significant pulmonary, metabolic or psychiatric disorders.
- Patients with known infectious diseases:
- Active hepatitis B infection ((hepatitis B surface antigen [HBsAg] positive) without receiving antiviral treatment.
- Positive test for hepatitis C ribonucleic acid (HCV) RNA).
- Pregnant or breastfeeding patients; patients of childbearing potential must use highly effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose...
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Lone Tree, Colorado, United States
- Fort Myers, Florida, United States
- Orlando, Florida, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Ithaca, New York, United States
- Syracuse, New York, United States
- Cleveland, Ohio, United States
- Maumee, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Tyler, Texas, United States
- Salt Lake City, Utah, United States
- Roanoke, Virginia, United States
+ 20 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 La Jolla, California, United States; Los Angeles, California, United States; San Diego, California, United States; Lone Tree, Colorado, United States; Fort Myers, Florida, United States; Orlando, Florida, United States and 34 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.