Clinical trial 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
- The study aims to find the safest dose of MCLA-158 and to learn how the drug behaves in the body and affects tumors.
- Who it's for
- Adults who have metastatic or advanced solid tumors, including colorectal, gastric, esophageal, lung, and head‑and‑neck cancers.
- What's involved
- Participants receive MCLA-158, either alone or with other cancer medicines, and undergo regular clinic visits for infusions, blood draws, and imaging scans to check safety and tumor response.
- Time commitment
- The trial runs for several months with multiple treatment and follow‑up visits throughout the study period.
- 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.
- Requirement for immunosuppressive medication (e.g. methotrexate, cyclophosphamide)
- Major surgery or radiotherapy within 3 weeks of the first dose of study treatment.
See the full eligibility criteria
- 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
- 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...
- The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, , as detected in plasma by ctDNA NGS central testing performed during screening.
- A microsatellite stable (MSS) tumor.
- Chemotherapy with oxaliplatin, irinotecan, and a fluoropyrimidine,
- 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.
- 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.
- 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 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...
- 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: i. Active hepatitis B infection (hepatitis B surface antigen [HBsAg] positive) without receiving antiviral treatment. ii.
- 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 is enrolling
- La Jolla, California, United States
- San Diego, California, United States
- Lone Tree, Colorado, United States
- Gainesville, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Ithaca, New York, United States
- New York, New York, United States
- Syracuse, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Maumee, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Tyler, Texas, United States
- Salt Lake City, Utah, United States
+ 21 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, but 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?
This study is enrolling now at La Jolla, California, United States; San Diego, California, United States; Lone Tree, Colorado, United States; Gainesville, Florida, United States; Orlando, Florida, United States; Atlanta, Georgia, United States and 35 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.