Approval Probability
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Also known as Ivonescimab Injection, Drug: Ivonescimab Injection, Drug: Ivonescimab
Ivonescimab · 10 trials · 24 indications
Time interval between the date of randomization and the date of intracranial progression or neurological related death, whichever occurs first
The objective response rate is defined as the percentage of patients with a complete response (CR) or a partial response (PR) for a given treatment
The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
The analysis of the primary efficacy endpoint will be conducted in all eligible patients, based on the disease control rate (DCR) at 12 weeks according to mRECIST 1.1 for mesothelioma, which was defined as the proportion of patients with compete response (CR), partial response (PR) or stable disease (SD) at 12 weeks as assessed by the independent review committtee.
ORR was defined as the percentage of participants achieving complete response (CR) and partial response (PR) on treatment based on RECIST v1.1 criteria.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
| Arm | Type | Description |
|---|---|---|
| Arm A - Ivonescimab | EXPERIMENTAL | Subject will receive ivonescimab as an IV injection |
| Arm B - Pembrolizumab | ACTIVE_COMPARATOR | Subject will receive pembrolizumab as an IV injection |
| Arm A - Ivonescimab and chemotherapy | EXPERIMENTAL | Subject will receive ivonescimab and chemotherapy |
| Arm B - Pembrolizumab and chemotherapy | ACTIVE_COMPARATOR | Subject will receive pembrolizumab and chemotherapy |
| Sequencing arm | EXPERIMENTAL | Patients will receive SRS/FSRT for all BM within ≤14 days from randomization, followed by 4 cycles of platinum-based chemotherapy combined with ivonescimab at 20 mg/kg every 3 weeks (Q3W). The systemic therapy will be followed by maintenance therapy with ivonescimab at 20 mg/kg plus pemetrexed (for patients with non-squamous NSCLC only) Q3W, for up to 2 years. |
| Systemic treatment alone arm | EXPERIMENTAL | Patients will receive 4 cycles of platinum-based chemotherapy combined with ivonescimab 20 mg/kg Q3W, followed by maintenance ivonescimab 20 mg/kg with pemetrexed (pemetrexed non-squamous only) Q3W for a maximum of 2 years. |
| Ivonescimab + FOLFIRI | EXPERIMENTAL | Ivonescimab 20 mg/kg by intravenous infusion (IV) once every 2 weeks (Q2W) combined with FOLFIRI chemotherapy (irinotecan 180 mg/m2 IV, folinic acid 400 mg/m2 IV (or L-folinic acid 200 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m2 as a 46 hour continuous IV infusion), every two weeks |
| Bevacizumab + FOLFIRI | ACTIVE_COMPARATOR | Bevacizumab 5 mg/kg by intravenous infusion (IV) once every 2 weeks (Q2W) combined with FOLFIRI chemotherapy (irinotecan 180 mg/m2 IV, folinic acid 400 mg/m2 IV (or L-folinic acid 200 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m2 as a 46 hour continuous IV infusion), every two weeks |
| 1st line | EXPERIMENTAL | FOLFOX combined with Ivonescimab |
| 2nd line | EXPERIMENTAL | Paclitaxel or Irinotecan (at investigator discretion) combined with ivonescimab |
| Experimental | EXPERIMENTAL | Experimental treatment under study |
| Control | ACTIVE_COMPARATOR | Standard of care second-line treatment for advanced biliary tract cancer |
| Ivonescimab | EXPERIMENTAL | 20 mg/kg IV (a fixed dose of 3200 mg for ivonescimab should be used for patients with weight ≥160 kg), every 3 weeks. |
| Cohort 1: Adenoid Cystic Carcinoma | EXPERIMENTAL | Approximately 11 participants will be enrolled to this cohort in the first stage of recruitment. If there are ≤2 participants (out of 22) with responses to the therapy, the accrual to the study will be stopped. If there are \>2 participants with response, accrual will continue. Enrolled participants will complete: * Baseline visit * Imaging tests every 9 weeks * Cycle 1 through End of Treatment (21 day cycles) --Day 1: Predetermined dose of Ivonescimab 1x daily. * End of treatment visit with imaging * Follow up: every 12 weeks |
| Cohort 2: Non-Adenoid Cystic Carcinoma Salivary Gland Carcinoma | EXPERIMENTAL | Approximately 11 participants will be enrolled to this cohort in the first stage of recruitment. If there are ≤2 participants (out of 22) with responses to the therapy, the accrual to the study will be stopped. If there are \>2 participants with response, accrual will continue. Enrolled participants will complete: * Baseline visit * Imaging tests every 9 weeks * Cycle 1 through End of Treatment (21 day cycles) --Day 1: Predetermined dose of Ivonescimab 1x daily. * End of treatment visit with imaging * Follow up: every 12 weeks |
| Cohort 1 | EXPERIMENTAL | Treatment with Ivonescimab (IV) Q3W For ACC |
| Cohort 2 | EXPERIMENTAL | Treatment with Ivonescimab (IV) Q3W For PPGL Suspended: No |
| PTX + IVO | EXPERIMENTAL | Treatment with Paclitaxel (IP) + Ivonescimab (IV) |
| Name | Type | Description |
|---|---|---|
| Ivonescimab Injection | BIOLOGICAL | Subject will receive ivonescimab as an IV injection |
| Pembrolizumab Injection | BIOLOGICAL | Subject will receive Pembrolizumab as an IV injection |
| ivonescimab | DRUG | ivonescimab iv at 20 mg/kg every 3 weeks |
| Bevacizumab | DRUG | Bevacizumab 5 mg/kg by intravenous infusion (IV) once every 2 weeks (Q2W) |
| FOLFIRI Protocol | DRUG | FOLFIRI chemotherapy (irinotecan 180 mg/m2 IV, folinic acid 400 mg/m2 IV (or L-folinic acid 200 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m2 as a 46 hour continuous IV infusion), every two weeks |
| FOLFOX regimen | DRUG | Oxaliplatin 85 mg/m2 IV, folinic acid 400 mg/m2 IV (or L-folinic acid 200 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m2 as a 46 hour continuous IV infusion, every two weeks for 8 cycles followed by 5FU as maintenance therapy until disease progression. |
| Irinotecan | DRUG | 180 mg/ m2 IV over 90 min infusion every two weeks for a minimum of 4 cycles |
| Paclitaxel | DRUG | 80 mg/m2 IV at D1, D8 and D15, every four weeks (D1=D28) |
| IP PTX | DRUG | Given by IP port |
Inclusion Criteria: * Age ≥ 18 years old at the time of enrollment * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1 * Expected life expectancy ≥ 3 months * Metastatic (Stage IV) NSCLC * Histologically or cytologically confirmed squamous or non-squamous NSCLC * Tumor dem...
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Ivonescimab is an investigational oncology therapy being studied for multiple cancers, including non-small cell lung cancer, extensive stage small cell lung cancer, squamous cell carcinoma of the head and neck, metastatic colorectal cancer, and metastatic esophageal adenocarcinoma. It is also being evaluated in trials for salivary gland cancer, gastric adenocarcinoma, and adrenocortical carcinoma.
Ivonescimab is a monoclonal antibody, indicated by its -mab suffix. Its specific molecular target is not disclosed in the available clinical trial information.
Ivonescimab is being developed by Summit Therapeutics Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SMMT.
Ivonescimab is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Multiple Phase 2 trials are currently recruiting or planned across various solid tumor indications.
Ivonescimab is being studied in several Phase 2 trials, including NCT06805617 for advanced or metastatic salivary gland cancers, NCT06846346 for gastric or gastroesophageal adenocarcinoma, NCT07234877 for non-small cell lung cancer with brain metastases, and NCT07743138 for adrenocortical carcinoma or pheochromocytoma/paraganglioma.
Yes, Ivonescimab is also referred to as Ivonescimab Injection, Ivonescimab 10 mg/kg, and Ivonescimab/kg in clinical trial documentation. These names refer to the same investigational drug product.