Last updated: July 1, 2026 — per-NCT detail accordions added (post-ASCO 2026)
At ASCO 2026 (June 9), cadonilimab featured as one of two bispecific-checkpoint stories carrying the PD-1/CTLA-4 + PD-1/TIGIT space into global Phase 3 expansion. The headline cadonilimab trial is adjuvant cadonilimab in HCC with high recurrence risk after curative resection (NCT05489289, Phase 3, recruiting) — the post-surgery curative-intent use of the bispecific in liver cancer. Cadonilimab remains an Akeso-led, China-anchored program with NMPA approvals in relapsed/metastatic cervical cancer (June 2022, monotherapy) and 1L gastric/GEJ adenocarcinoma in combination with chemotherapy (2023); it is not FDA-approved and has no other regulatory approvals outside Greater China.
Cadonilimab (development code AK104; brand name Kaitanni / 开坦尼 in China) is a tetravalent bispecific antibody developed by Akeso Biopharma. It simultaneously blocks two T-cell inhibitory checkpoints — PD-1 and CTLA-4 — in a single molecule, with the Fc region engineered to be silent (no antibody-dependent cellular cytotoxicity).
Mechanism of action:Because PD-1 and CTLA-4 are co-expressed on exhausted tumor-infiltrating lymphocytes but only sparsely co-expressed in peripheral tissue, the tetravalent bispecific design binds with higher avidity inside the tumor microenvironment than in the systemic circulation. The clinical rationale is to recover the anti-tumor activity of CTLA-4 pathway blockade (the active ingredient in ipilimumab + nivolumab regimens) while limiting the systemic immune-related toxicity that has historically constrained CTLA-4 use.
Regulatory status:Cadonilimab was the world's first approved bispecific PD-1/CTLA-4 antibody. China's NMPA approval timeline: June 2022 for relapsed/metastatic cervical cancer after platinum chemotherapy (monotherapy); 2023 for first-line gastric / gastroesophageal junction adenocarcinoma in combination with chemotherapy; subsequent expansions across additional indications. Not FDA-approved. A large recruiting pipeline of confirmatory and expansion trials — including 10 Phase 3 studies — is now underway across most major solid tumors.
Approved 1L indication in China (NMPA 2023 for 1L gastric/GEJ in combination with chemotherapy). Active Phase 3 expansions in perioperative and second-line settings, plus HER2-expressing post-1L combinations:
First-approved indication (NMPA June 2022 for r/m post-platinum monotherapy). Current pipeline focuses on locally advanced disease and concurrent chemoradiation:
A major Phase 3 focus and the cadonilimab indication highlighted in the ASCO 2026 wrap-up (takeaway #6). Two distinct strategies — adjuvant high-risk-recurrence and intermediate-stage TACE potentiation:
Active development in both MSS (combined with anti-angiogenics + SBRT) and MSI-H (neoadjuvant resectable) populations:
Phase 3 pivotal in unresectable locally advanced disease (consolidation after chemoradiation), plus 1L PD-L1-negative and perioperative strategies:
Bispecific-on-bispecific combinations (cadonilimab + ivonescimab) are a distinctive Akeso strategy in SCLC:
Active across locally advanced neoadjuvant and perioperative settings:
A Chinese-prevalent disease where Akeso has invested heavily; Phase 3 in locally advanced and recurrent/metastatic NPC:
Showing pivotal Phase 3 / Phase 2-3 trials plus selected Phase 2 trials across major indications. The full set of 73 recruiting interventional studies includes additional investigator-initiated combinations not listed above. View the latest on ClinicalTrials.gov.
Detailed accordions for five high-visibility cadonilimab (AK104) Phase 3 trials currently recruiting, spanning HCC, gastric/GEJ, NSCLC, cervical, and colorectal cancers. Each accordion summarizes the trial's setting, eligibility highlights, and a direct route into ClinTrialFinder's patient-matching wizard. All entries cross-checked against the live ClinicalTrials.gov record on June 14, 2026.
Official title: A Randomized, Double-blind, Phase III Clinical Study on the Efficacy and Safety of AK104 Versus Placebo as Adjuvant Therapy for Hepatocellular Carcinoma With High Risk of Recurrence After Curative Resection
Sponsor: Akeso
Phase: 3 | Status: RECRUITING | Setting: Adjuvant after radical resection in HCC with high recurrence-risk factors, Child-Pugh A, ECOG 0
Why this trial matters: The cadonilimab trial named in the ASCO 2026 wrap-up (takeaway #6) as a representative Phase 3 anchor for the PD-1/CTLA-4 bispecific class. Post-resection HCC has no established adjuvant IO standard (IMbrave050 with atezolizumab + bevacizumab did not meet the OS endpoint at interim); a positive AK104 adjuvant readout would open the post-curative-intent IO window in liver cancer. Planned enrollment 570.
Eligibility highlights: Pathological HCC diagnosis without metastasis, radical resection as the only prior anti-tumor treatment, no residual cancer during or after surgery, presence of any high-risk recurrence factor, Child-Pugh A, ECOG 0, controlled underlying liver disease. Excludes fibrolamellar / sarcoma-like / cholangiocarcinoma histologies and any non-surgical anti-tumor treatment before randomization. Full eligibility on ClinicalTrials.gov.
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External reference: View NCT05489289 on ClinicalTrials.gov
Official title: A Randomized, Double-blind, Phase III Clinical Study Comparing the Efficacy and Safety of Cadonilimab Plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) as Perioperative Treatment for Patients With Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor: Akeso
Phase: 3 | Status: RECRUITING | Setting: Resectable gastric / GEJ adenocarcinoma, clinical stage T3–4aN+M0 or T4bNanyM0 per AJCC 8th edition; perioperative (neoadjuvant + adjuvant) with SOX backbone
Why this trial matters: Builds on the 2023 NMPA approval of cadonilimab + chemotherapy in 1L gastric/GEJ by extending the bispecific into the perioperative resectable setting, where pembrolizumab + chemo (KEYNOTE-585) and durvalumab + FLOT (MATTERHORN) have produced mixed-to-positive event-free survival results. Planned enrollment 760.
Eligibility highlights: Histologically confirmed gastric or GEJ adenocarcinoma with resectable disease (T3–4aN+M0 or T4bNanyM0 per AJCC 8th), ECOG 0–1, life expectancy ≥ 6 months, tumor sample available pre-study, planned radical surgery, adequate organ function. Excludes unresectable LA disease and distant metastasis. Full eligibility on ClinicalTrials.gov.
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External reference: View NCT07023315 on ClinicalTrials.gov
Official title: A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Consolidation Therapy of AK104 Versus Sugemalimab in Patients With Unresectable Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed Following Concurrent or Sequential Chemoradiotherapy
Sponsor: Akeso
Phase: 3 | Status: RECRUITING | Setting: Unresectable locally advanced (Stage III) NSCLC after concurrent or sequential chemoradiation, no EGFR-sensitizing mutations, ALK-/ROS1-negative
Why this trial matters: Direct Phase 3 head-to-head of a PD-1/CTLA-4 bispecific against sugemalimab (PD-L1 monoclonal, approved in China for the same Stage III NSCLC consolidation slot via GEMSTONE-301). A positive readout would establish dual checkpoint blockade as superior to single-axis PD-L1 monotherapy in the post-chemoradiation consolidation window. Planned enrollment 560.
Eligibility highlights: Age ≥ 18, histologically or cytologically confirmed unresectable LA (Stage III) NSCLC, absence of known EGFR-sensitizing mutations, ALK and ROS1 fusion-negative, concurrent or sequential chemoradiation completed 1–42 days prior to first dose, no post-radiation consolidation chemotherapy, total radiotherapy dose 60 Gy (per protocol). Full eligibility on ClinicalTrials.gov.
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External reference: View NCT06617416 on ClinicalTrials.gov
Official title: A Phase III, Multicenter, Open-label, Randomized Controlled Clinical Study on the Treatment of Locally Advanced Cervical Cancer With Cadonilimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Standard CCRT
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (collaborator: Akesobio)
Phase: 3 | Status: RECRUITING | Setting: Locally advanced cervical cancer (FIGO 2018 Stage IIB–IVA), no prior antineoplastic therapy, squamous / adenocarcinoma / adenosquamous histology
Why this trial matters: Builds on cadonilimab's first-approved indication (NMPA June 2022 for r/m cervical) by moving the PD-1/CTLA-4 bispecific upstream into LACC, where the current standard is concurrent platinum-based chemoradiation. Tests whether adding induction cadonilimab + chemo before CCRT improves PFS over CCRT alone — the same architecture that pembrolizumab + chemo + CCRT used in KEYNOTE-A18. Planned enrollment 378.
Eligibility highlights: Female, age 18–70 inclusive, histologically confirmed squamous / adenocarcinoma / adenosquamous cervical carcinoma, FIGO 2018 Stage IIB–IVA, no prior antineoplastic therapy, at least one measurable lesion per RECIST 1.1, ECOG 0–1, adequate organ function. Full eligibility on ClinicalTrials.gov.
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External reference: View NCT07400536 on ClinicalTrials.gov
Official title: Study of Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer
Sponsor: Caigang Liu (investigator-sponsored study)
Phase: 3 | Status: RECRUITING | Setting: 1L recurrent or metastatic MSS colorectal adenocarcinoma in patients with RAS mutation or right-sided primary — the populations where anti-EGFR therapy is contraindicated or underperforms
Why this trial matters: RAS-mutated and right-sided mCRC are biologically harder subsets where the anti-EGFR option (cetuximab / panitumumab) is ineffective or net-harmful. This trial layers PD-1/CTLA-4 bispecific blockade onto the standard chemo + bevacizumab backbone for exactly the patient population without a strong targeted-therapy alternative. Note: planned enrollment is small (30) — this is a focused investigator-sponsored Phase 3, not a large registrational study.
Eligibility highlights: Age 18–75, ECOG 0–1, life expectancy ≥ 3 months, histologically confirmed recurrent or incurable metastatic colorectal adenocarcinoma (UICC), RAS-mutated or right-sided primary, MSS / pMMR status. Full eligibility on ClinicalTrials.gov.
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External reference: View NCT06566755 on ClinicalTrials.gov
Cadonilimab trials do not converge on a single biomarker the way RET inhibitors or HER2-ADCs do — checkpoint blockade benefits are biology-broad. The most commonly used enrichment or stratification markers in the cadonilimab pipeline are:
What is cadonilimab?
Cadonilimab (development code AK104, brand name Kaitanni / 开坦尼 in China) is a tetravalent bispecific antibody that simultaneously blocks PD-1 and CTLA-4. Developed by Akeso Biopharma, it was the world's first bispecific PD-1/CTLA-4 antibody to receive regulatory approval (China NMPA, June 2022 for relapsed/metastatic cervical cancer). It is not currently FDA-approved.
How is cadonilimab different from combining nivolumab and ipilimumab?
The therapeutic concept — block both PD-1 and CTLA-4 — is the same, but the design is different. Cadonilimab is a single tetravalent molecule with the Fc engineered to be silent. Because PD-1 and CTLA-4 are co-expressed on tumor-infiltrating lymphocytes but only sparsely co-expressed in peripheral tissue, the bispecific binds with higher avidity inside tumors than in peripheral organs. In published trials, Grade 3+ immune-related adverse-event rates have generally been lower than the ipilimumab + nivolumab combination. Head-to-head comparisons are not yet available.
What cadonilimab trials are currently recruiting?
There are 73 recruiting interventional cadonilimab trials as of July 2026 (post-ASCO 2026), including 12 Phase 3 / Phase 2-3 pivotal studies. The largest indication clusters are colorectal cancer (12 trials), gastric/GEJ adenocarcinoma (12), cervical cancer (9), hepatocellular carcinoma (8), NSCLC (6), and pancreatic cancer (4). Most studies are sponsored or led from China, where cadonilimab is approved, and most combine cadonilimab with chemotherapy, anti-angiogenics (lenvatinib, bevacizumab, fruquintinib, anlotinib), HER2-directed therapy, or radiation. The ASCO 2026 wrap-up takeaway #6 highlights the cadonilimab adjuvant HCC Phase 3 (NCT05489289) as a representative Phase 3 anchor for the PD-1/CTLA-4 bispecific class.
What are the main side effects of cadonilimab?
Side effects are immune-related: hypothyroidism, skin rash and pruritus, fatigue, immune-mediated colitis, hepatitis, and pneumonitis. Reported Grade 3+ immune-related event rates have generally been lower than ipilimumab + nivolumab combinations, but combination regimens add the toxicities of the partner drug (myelosuppression and neuropathy from chemotherapy; hypertension and proteinuria from lenvatinib or bevacizumab). Pre-existing autoimmune disease requires careful pre-treatment evaluation.
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