Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
I-131-CLR1404 · 3 trials · 3 indications
DLT will be assessed by physical examination, vital signs, ECG, and laboratory values
Largest administered dose with at most a 20% dose limiting toxicity rate
| Arm | Type | Description |
|---|---|---|
| Single | EXPERIMENTAL | I-131-CLR1404 with or without concurrent dexamethasone |
| Single Group | OTHER | I-131-CLR1404 |
| Name | Type | Description |
|---|---|---|
| I-131-CLR1404 | DRUG | Single intravenous injection of 10 millicuries of I-131-CLR1404 given on Day 0 |
| dexamethasone | DRUG | 40 mg dexamethasone orally once weekly for up to 12 weeks |
Inclusion Criteria: * Histologically or cytologically confirmed multiple myeloma * Prior treatment with or intolerance to proteasome inhibitor and immunomodulator * Bone marrow biopsy within 28 days of study drug infusion demonstrating at least 5% plasma cell involvement * Progressive disease defin...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
I-131-CLR1404 is an investigational small molecule being studied in oncology for the treatment of cancer, solid tumors, and multiple myeloma. It is a radiolabeled compound that has been evaluated in Phase 1 clinical trials for patients with relapsed or refractory advanced solid tumors and multiple myeloma.
I-131-CLR1404 is being developed by Cellectar Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLRB. The company has sponsored clinical trials of this investigational agent in patients with advanced cancers.
I-131-CLR1404 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Three Phase 1 studies of the agent have been completed, including trials in solid tumors, cancer, and multiple myeloma.
I-131-CLR1404 has been studied in three completed Phase 1 clinical trials. NCT00925275 was a dosimetry study in patients with relapsed or refractory advanced solid tumors. NCT01495663 was a dose escalation study in cancer patients whose disease did not respond to treatment or had returned. NCT02278315 was a dose escalation study in patients with relapsed or refractory multiple myeloma.
A total of 31 patients have been enrolled across the completed Phase 1 clinical trials of I-131-CLR1404. The multiple myeloma study NCT02278315 enrolled 31 patients, the dose escalation cancer study NCT01495663 enrolled 12 patients, and the solid tumor dosimetry study NCT00925275 enrolled 9 patients.
I-131-CLR1404 is a radiolabeled form of the investigational agent CLR1404, where iodine-131 is attached to the molecule. The compound is being developed by Cellectar Biosciences for use in oncology, and the completed Phase 1 trials have evaluated its safety and dosing in patients with advanced cancers.