Clinical trial · Interventional
Study of Dalotuzumab Alone and With Ridaforolimus in Pediatric Participants With Advanced Solid Tumors (MK-8669-062 AM1)
A Phase I Study of Monotherapy Dalotuzumab and Ridaforolimus-Dalotuzumab Combination Treatment in Pediatric Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a study of dalotuzumab given as monotherapy and in combination with ridaforolimus for pediatric participants with advanced solid tumors. This study will have three parts. Part 1 will find a maximum tolerated dose (MTD) and collect pharmacokinetic (PK) data for dalotuzumab alone. Part 2 will find an MTD and collect PK data for dalotuzumab in combination with ridaforolimus. Part 3 will be an expansion cohort at the recommended Phase 2 dose (RPTD) found in Part 2 to confirm the RPTD and look at the potential efficacy of the combination therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dalotuzumab | Drug | — | UNRESOLVED |
| ridaforolimus | Drug | Ridaforolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1: Dalotuzumab
- interventionNames
- Drug: dalotuzumab
- type
- EXPERIMENTAL
- label
- Parts 2 and 3: Dalotuzumab + ridaforolimus
- interventionNames
- Drug: dalotuzumab
- Drug: ridaforolimus
Primary outcomes (5)
- measure
- Number of participants with dose limiting toxicities (DLTs) while receiving dalotuzumab alone
- timeFrame
- First 21 days of treatment
- measure
- Number of participants with DLTs while receiving dalotuzumab and ridaforolimus combination therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion criteria: * Participants of age 3 to 17 years for Part 1 of the study and age 6 to 17 years for Parts 2 and 3 of the study * Histologic or cytologic diagnosis of a malignant solid tumor, including tumors of the central nervous system and lymphoma, that have progressed despite standard therapy or for which no effective standard therapy is known. * Measurable or non-measurable disease for Parts 1 and 2; measurable disease for Part 3 * Parts 2 and 3: must be able to swallow tablets * Performance Status: Lansky Play Scale ≥70 for children \<10 years of age; Karnofsky score ≥70 for children ≥10 to \<16 years; or Eastern Cooperative Oncology Group (ECOG) Status 0-2 for patients age 16 and older * Adequate organ function * For females of reproductive potential, a negative pregnancy test must be documented within 72 hours of receiving the first dose of study medication * Participants of reproductive potential must agree to use (or have their partner use) adequate contraception throughout the study, starting with Visit 1 through 30 days after the last dose of study drug Exclusion criteria: * Currently receiving any other investigational agents or using any investigational devices * Leukemia * Previously received dalotuzumab or other IGF-1R inhibitors for Part 1 * History of allergic reactions attributed to compounds of similar chemical or biologic composition to dalotuzumab or ridaforolimus * Persistent acute toxicity from previous therapy ≥Grade 2 (excluding alopecia, neuropathy, or hearing loss) * Uncontrolled intercurrent illness despite adequate therapy * Pregnant or breastfeeding * For Parts 2 and 3: requirement for concurrent treatment with medications that are inducers or inhibitors of cytochrome P450 (CYP3A) * Poorly controlled Type 1 or 2 diabetes
References
Publications (1)
- RESULTFrappaz D, Federico SM, Pearson AD, Gore L, Macy ME, DuBois SG, Aerts I, Iannone R, Geschwindt R, Van Schanke A, Wang R, Geoerger B. Phase 1 study of dalotuzumab monotherapy and ridaforolimus-dalotuzumab combination therapy in paediatric patients with advanced solid tumours. Eur J Cancer. 2016 Jul;62:9-17. doi: 10.1016/j.ejca.2016.03.084. Epub 2016 May 10. PMID 27185573