Clinical trial · Interventional
A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
A Dose-escalation Study of R1507 in 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 study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is \<100 individuals.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RG1507 | Drug | Teprotumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: RG1507
Primary outcomes (1)
- measure
- AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life
- timeFrame
- Throughout study
Secondary outcomes (1)
- measure
- Tumor response
- timeFrame
- Event driven
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, \>=18 years of age; * solid neoplasm, non-Hodgkin's lymphoma or Hodgkin's lymphoma; * metastatic or locally advanced disease, not curable by any currently available treatment. Exclusion Criteria: * severe, uncontrolled systemic disease; * patients who require treatment with glucocorticoids or immunosuppressive treatment within last 6 months; * patients with diabetes mellitus.
References
Publications (1)
- DERIVEDXin Y, Xu F, Gao Y, Bhatt N, Chamberlain J, Sile S, Hammel S, Holt RJ, Ramanathan S. Pharmacokinetics and Exposure-Response Relationship of Teprotumumab, an Insulin-Like Growth Factor-1 Receptor-Blocking Antibody, in Thyroid Eye Disease. Clin Pharmacokinet. 2021 Aug;60(8):1029-1040. doi: 10.1007/s40262-021-01003-3. Epub 2021 Mar 26. PMID 33768488