EUCTR2017-004745-24-BE招募中1 期
Phase 1/2 dose escalation and cohort expansion study evaluating MCLA-158 (Petosemtamab) as single agent or in combination in advanced solid tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Merus N.V.
- 入组人数
- 567
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1 Signed ICF
- •2 Age = 18 y
- •3. Histologically/cytologically confirmed solid tumors with evidence of
- •metastatic or locally advanced disease not amenable to standard therapy
- •with curative intent:
- •Expansion cohorts: patients (pts) with locally advanced unresectable
- •or metastatic disease for the following indications:
- •oSINGLE AGENT
- •o2nd/3rd-LINE HNSCC PATIENTS: pts who have progressed on or after,
- •or are intolerant to, anti-PD-(L)1 therapy as monotherapy or in
- •combination , and have progressed to a Pt-based chemotherapy less
- •than 6 months from the last Pt dose, with no previous EGFR inhibitors.
- •Pts with no more than 2 prior lines of treatment in recurrent or
- •metastatic disease not amenable to standard therapy with curative
- •HPV status by p16 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.
- •oCancers of the anogenital tract with squamous cell histology
- •oNSCLC non-SCC and SCC
- •oGEA with histologically confirmed EGFR amplification FISH score
- •EGFR/CEP7 ratio =2.0, or NGS EGFR copy =8, or cfDNA =2.5, or EGFR
- •IHC H-score =200)
- •o mCRC in 3L+. Patients should be free of mutations in RAS, KRAS,
- •NRAS, HRAS, RAF, BRAF, ARAF, RAF1,
- •If the patient was treated with an EGFR inhibitor in 1L or 2L, then the
- •patient should have shown CR)/PR and should have at least 6 months of
- •interval since the last administration of EGFR inhibitor.
- •oCOMBINATION
- •o1st HNSCC: pts eligible to receive pembro. as 1st-line monotherapy
- •with tumors expressing PD-L1, CPS =1; pts should not have previous
- •systemic therapy in the
- •recurrent or metastatic setting, although previous systemic therapy as
- •part of multimodal treatment for locally advanced disease is allowed if
- •ended =6 months prior to signing the ICF. The eligible HNSCC primary
- •tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- •Previous treatments with anti-PD-(L)1 or anti-EGFR therapies are not
- •2L mCRC: Patients should have been previously diagnosed with
- •histologically or cytologically confirmed unresectable or metastatic
- •adenocarcinoma of the CRC. Patients must be RAS/RAF WT . Patients
- •must be naive to prior anti-EGFR . Radiographically confirmed disease
- •progression must have occurred within 6 months of prior 1L.
- •o Cohort petosemtamab and FOLFIRI: patients should have had only 1
- •prior chemotherapy regimen for the metastatic setting, consisting of 1L
- •fluoropyrimidine-oxaliplatin-based chemotherapy ± bevacizumab. Note:
- •FOLFOX-based adjuvant treatment would be considered front-line if PD
- •occurred within 6 months of completion of adjuvant therapy.
- •o Cohort petosemtamab and FOLFOX: patients should have had only 1
- •prior chemotherapy regimen for the metastatic setting, consisting of 1L
- •fluoropyrimidine-irinotecan-based chemotherapy ± bevacizumab.
- 另有 13 项未显示
排除标准
- •1. 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.
- •2. Known leptomeningeal involvement
- •3. Participation in another clinical study or treatment with any
- •IMP within 4 weeks prior to study entry
- •4. 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 (eg, mitomycin C, nitrosoureas),
- •or anticancer immunotherapies, a washout period of 6 weeks is required.
- •5. Requirement for immunosuppressive medication
- •6. 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.
- •7. Persistent Grade >1 clinically significant toxicities related to prior
- •antineoplastic therapies (except for alopecia); stable sensory
- •neuropathy Grade =2 v4.03 is allowed.
- •8. History of hypersensitivity reaction to any of the excipients of
- •petosemtamab, human proteins, or any non-IMP treatment required for
- •9. Uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg
- •and/or diastolic BP >100 mmHg) with appropriate treatment; unstable
- •angina; history of congestive heart failure of Class II-IV New York Heart
- •Association (NYHA) criteria, or serious cardiac arrhythmia requiring
- •treatment; or history of myocardial infarction within 6 months of
- •study entry
- •10. 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 years.
- •11. Current dyspnea at rest of any origin, or other diseases requiring
- •continuous oxygen therapy, including patients with a history of
- •interstitial lung disease (ILD) (eg, pneumonitis or pulmonary fibrosis),
- •or evidence of ILD on baseline chest computerized tomography (CT)
- •12. Current serious illness or medical conditions including, but not
- •limited to, uncontrolled active infection, clinically significant pulmonary,
- •metabolic, or psychiatric disorders
- •13. Patients with known infectious diseases:
- •Active hepatitis B infection without receiving antiviral treatment. Note:
- •o Patients who are HbsAg positive must receive antiviral treatment with
- •lamivudine, tenofovir, entecavir, or other antiviral agents, starting at
- •least =7 days before the initiation of study treatment.
- •o Patients with antecedents of hepatitis B (eg, anti-hepatitis B core
- •(anti-HBc) positive, HbsAg, and hepatitis B virus [HBV] DNA negative)
- •are eligible.
- •Positive test for hepatitis C virus (HCV) RNA. Note: Patients in whom
- •HCV infection resolved spontaneously (ie, positive HCV antibodies
- •without detectable HCV RNA), or who achieved a sustained response
- •after antiviral treatment and show absence of detectable HCV RNA =6
- •months (with the use of interferon [IFN]-free regimens) or =12 months
- •(with the use of IFN-based regimens) after cessation of antiviral
- 另有 7 项未显示
研究者
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