Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AK112 Injection
AK112 · 2 trials · 2 indications
Progression-free survival (PFS) assessed by IRC per RECIST v1.1 in the ITT population.
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
| Arm | Type | Description |
|---|---|---|
| AK112 in combination with Pemetrexed and Carboplatin | EXPERIMENTAL | Subjects will receive AK112 Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles. Afterward, AK112 Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years. |
| Placebo in combination with Pemetrexed and Carboplatin | ACTIVE_COMPARATOR | Subjects will receive Placebo Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles in treatment periods per the randomization schedule. Afterward, Placebo Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years. |
| Part 1_Chemotherapy Regimen Selection Stage Group A(AK112+AK117+XELOX) | EXPERIMENTAL | AK112+AK117+XELOX AK112 and AK117 and XELOX(Oxaliplatin 130 mg/sqm iv day 1, Capecitabine via oral, the total daily dose was 2000mg/sqm, day1-14) If no progression occurs during AK112 plus AK117 plus XELOX, patients will receive maintenance capecitabine plus AK112 plus AK117 at the same dose used at the last cycle of the induction treatment. Capecitabine plus AK112 plus AK117 will be repeated every 3 weeks until disease progression, unacceptable toxicity or patient's refusal. |
| Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI) | EXPERIMENTAL | AK112+AK117+FOLFOXIRI AK112 and AK117 and FOLFOXIRI(Irinotecan 150-165 mg/sqm iv day 1, Oxaliplatin 85 mg/sqm iv day 1, Leucovorin(LV) 400 mg/sqm iv day 1, 5-fluorouracil(5-FU) 2400-2800 mg/sqm 46-48 hours continuous infusion, starting on day 1) If no progression occurs during AK112 plus AK117 plus FOLFOXIRI, patients will receive maintenance 5-FU/LV plus AK112 plus AK117 at the same dose used at the last cycle of the induction treatment. 5-FU/LV plus AK112 plus AK117 will be repeated biweekly until disease progression, unacceptable toxicity or patient's refusal. |
| Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy) | EXPERIMENTAL | AK112 (Dose1) +Chemotherapy(Decided by Chemotherapy Regimen Selection Stage) AK112 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage) |
| Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy) | EXPERIMENTAL | AK112 (Dose1) +AK117 (Dose1) +Chemotherapy(Decided by Chemotherapy Regimen Selection Stage) AK112 and AK117 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage) |
| Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy) | EXPERIMENTAL | AK112 (Dose2)+Chemotherapy(Decided by Chemotherapy Regimen Selection Stage). AK112 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage). |
| Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy) | EXPERIMENTAL | AK112(Dose2) + AK117(Dose2)+Chemotherapy(Decided by Chemotherapy Regimen Selection Stage) AK112 and AK117 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage) |
| Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy) | EXPERIMENTAL | AK112(Dose2)+AK117(Dose1)+Chemotherapy(Decided by Chemotherapy Regimen Selection Stage) AK112 and AK117 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage) |
| Part 1_Extension Stage Group F (AK112 DS1 + mFOLFOX6) | EXPERIMENTAL | AK112 (Dose1) +mFOLFOX6 ( Oxaliplatin 85 mg/sqm IV day 1, Leucovorin 400 mg/sqm IV day 1, 5-fluorouracil(5-FU) 2400 mg/sqm 46-48 hours continuous infusion, starting on day 1). If no progression occurs during AK112 plus mFOLFOX6, patients will receive maintenance 5- FU/LV plus AK112 at the same dose used at the last cycle of the induction treatment. 5-FU/LV plus AK112 will be repeated biweekly until disease progression, unacceptable toxicity or patient's refusal. |
| Part 1_Extension Stage Group G (AK112 DS2+mFOLFOX6) | EXPERIMENTAL | AK112 (Dose2) +mFOLFOX6 ( Oxaliplatin 85 mg/sqm IV day 1, Leucovorin 400 mg/sqm IV day 1, 5-fluorouracil(5-FU) 2400 mg/sqm 46-48 hours continuous infusion, starting on day 1) If no progression occurs during AK112 plus mFOLFOX6, patients will receive maintenance 5- FU/LV plus AK112 at the same dose used at the last cycle of the induction treatment. 5-FU/LV plus AK112 will be repeated biweekly until disease progression, unacceptable toxicity or patient's refusal. |
| Part 2 cohort 1(AK112) | EXPERIMENTAL | Subjects receive AK112 until disease progression or unacceptable toxicity AK112 (until disease progression, unacceptable toxicity or patient's refusal) |
| Part 2 cohort 2(AK112+AK117) | EXPERIMENTAL | Subjects receive AK117 and AK112 until disease progression or unacceptable toxicity AK112 and AK117 ( until disease progression, unacceptable toxicity or patient's refusal) |
| Name | Type | Description |
|---|---|---|
| AK112 Injection | DRUG | Subjects will receive AK112 Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles. Afterward, AK112 Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years. |
| Placebo Injection | DRUG | Subjects will receive Placebo Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles in treatment periods per the randomization schedule. Afterward, Placebo Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years. |
| AK112 | DRUG | AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity |
| AK117 | DRUG | AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity |
| Oxaliplatin | DRUG | Oxaliplatin via IV infusion |
| Capecitabine | DRUG | Capecitabine via oral,The total daily dose was 2000mg/sqm, Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days |
| Irinotecan | DRUG | Irinotecan via IV infusion |
| Leucovorin | DRUG | Leucovorin via IV infusion |
| 5-fluorouracil | DRUG | 5-fluorouracil via IV infusion |
Inclusion Criteria: 1. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed. 2. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. (For patient...
AK112 is an investigational oncology drug being studied for Non-Squamous Non-small Cell Lung Cancer and Metastatic Colorectal Cancer. It is currently in clinical development and has not been approved by the FDA.
AK112 targets PD-1, a protein involved in immune checkpoint regulation. By targeting PD-1, AK112 is designed to modulate the immune system's response to cancer cells.
AK112 is being developed by Summit Therapeutics Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol SMMT.
AK112 is in Phase 2 and Phase 3 clinical trials. It is being studied in active trials for Non-Squamous Non-small Cell Lung Cancer and Metastatic Colorectal Cancer, and is not yet approved.
AK112 is being studied in two active clinical trials. NCT05382442 is a Phase 2 study of AK112 with or without AK117 in Metastatic Colorectal Cancer. NCT06396065 is a Phase 3 study of AK112 for Non-Squamous Non-small Cell Lung Cancer.
Yes, AK112 is also known as AK112 Injection. Both names refer to the same investigational drug being developed by Summit Therapeutics Inc.