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Advanced Malignant TumorsPhase 1/2NCT05229497

A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors

A Phase 1/2 study testing AK112, AK117 and Carboplatin in people with Advanced Malignant Tumors, run by Akeso at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK112 (anti-PD-1 and VEGF bispecific antibody) combined with AK117#AntiCD47 Antibody# in advanced malignant tumors Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignant Tumors
What is being tested?
AK112, AK117 and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteChina
Study dates
4 May 2022to 30 Jun 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 to 75 years old.
  • Have a life expectancy of at least 3 months.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Phase Ib: Histologically or cytologically confirmed selected advanced solid tumor.
  • Phase II: Subjects were patients with recurrent/metastatic HNSCC diagnosed histologically and/or cytologically that could not be completely resected surgically and could not be treated with radical simultaneous radiotherapy, or local and or neck recurrence after radical surgery that had progressed with radiotherapy or were unsuitable for radiotherapy.
  • Cohort 1 and 2 :
Show all 11Show fewer
  • Recurrent or metastatic HNSCC (non-nasopharyngeal carcinoma) that has not received systemic antitumour therapy for previous recurrent or metastatic stage and has positive PD-L1 expression (CPS ≥ 1); for subjects who have received previous adjuvant/neoadjuvant chemotherapy for non-metastatic disease with curative intent or radical radiotherapy for locally advanced disease, if disease progression occurs after the end of the last chemotherapy session ≥ 6 months, are eligible to participate in this cohort.
  • Cohort 3: Recurrent or metastatic HNSCC (non-nasopharyngeal carcinoma) that has not received systemic antitumour therapy for prior recurrent or metastatic stages; for subjects who have received prior adjuvant/neoadjuvant chemotherapy for non-metastatic disease with curative intent, or radical radiotherapy for locally advanced disease, are eligible to participate in this cohort if disease progression occurs ≥6 months after the end of the last chemotherapy treatment.
  • Cohort 4: Recurrent or metastatic nasopharyngeal carcinoma that has not received systemic antitumour therapy for prior recurrent or metastatic stages; for subjects who have received prior adjuvant/neoadjuvant chemotherapy for non-metastatic disease with curative intent or radical radiotherapy for locally advanced disease, they are eligible for this cohort if disease progression occurs ≥ 6 months after the end of the last chemotherapy treatment. Note: Subjects with recurrent or residual primary foci after radiotherapy are excluded, and subjects with adenocarcinoma or sarcoma of the nasopharynx are excluded.
  • Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
  • Has adequate organ function.

Who cannot join

  • Undergone major surgery within 30 days prior to the first dose of study treatment.
  • Active central nervous system (CNS) metastases.
  • History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
  • Active Hepatitis B or Hepatitis C.
  • Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
  • History of severe bleeding tendency or coagulation disorder.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Official title: A Phase Ib/II Study of AK112#PD-1/VEGF Bispecific Antibody# in Combination With AK117#Anti-CD47 Antibody# in Advanced Malignant Tumors

Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK112 (anti-PD-1 and VEGF bispecific antibody) combined with AK117#AntiCD47 Antibody# in advanced malignant tumors

Being tested
AK112, AK117, Carboplatin, Cisplatin, 5-Fluorouracil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK112Drug

    IV infusion,Specified dose on specified days

  • AK117Drug

    IV infusion,Specified dose on specified days

  • CarboplatinDrug

    IV infusion,Specified dose on specified days

  • CisplatinDrug

    IV infusion,Specified dose on specified days

  • 5-FluorouracilDrug

    IV infusion,Specified dose on specified days

  • GemcitabineDrug

    IV infusion,Specified dose on specified days

Study groups in NCT05229497
Study groupRoleWhat they receive
Phase Ib#Dosage regimen 1#ExperimentalSubjects receive AK112 (20 mg/kg Q3W) + AK117 (30 mg/kg QW)
Receives: Drug: AK112; Drug: AK117
Phase Ib#Dosage regimen 2#ExperimentalSubjects receive AK112 (20 mg/kg Q3W) + AK117 (45 mg/kg QW)
Receives: Drug: AK112; Drug: AK117
Phase II#Cohort 1#ExperimentalHead and neck squamous cell carcinoma (HNSCC): AK112 (20 mg/kg Q3W)
Receives: Drug: AK112
Phase II#Cohort 2#ExperimentalHNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)
Receives: Drug: AK112; Drug: AK117
Phase II#Cohort 3#ExperimentalHNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)+Carboplatin/Cisplatin+5-fluorouracil
Receives: Drug: AK112; Drug: AK117; Drug: Carboplatin; Drug: Cisplatin; Drug: 5-Fluorouracil
Phase II#Cohort 4 regimen 1#ExperimentalNasopharyngeal Carcinoma: AK112 (10 mg/kg d1 Q3W) + AK117（recommended Phase 2 dose）+ Cisplatin (80 mg/m2 d1 Q3W)+Gemcitabine (1000 mg/m2 d1, d8 Q3W)
Receives: Drug: AK112; Drug: AK117; Drug: Cisplatin; Drug: Gemcitabine
Phase II#Cohort 4 regimen 2#ExperimentalNasopharyngeal Carcinoma: AK112 (10 mg/kg d1 Q3W) + Cisplatin (100 mg/m2 d1 Q3W)+Gemcitabine (1000 mg/m2 d1, d8 Q3W)
Receives: Drug: AK112; Drug: Cisplatin; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with Adverse Events (AEs)

    Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs

    Measured: Up to approximately 2 years

  2. Number of patients experiencing dose-limiting toxicities (DLTs)

    Measured: During the first 3 weeks

  3. Objective Response Rate (ORR)

    Measured: Up to approximately 2 years

Secondary outcomes (5)

  1. Disease control rate (DCR)

    Measured: Up to approximately 2 years

  2. Duration of Response (DOR)

    Measured: Up to approximately 2 years

  3. Time to response (TTR)

    Measured: Up to approximately 2 years

  4. Progression free survival (PFS)

    Measured: Up to approximately 2 years

  5. Overall survival (OS)

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start4 May 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05229497
Sponsor's protocol ID
AK117-201
Status last verified
Mar 2026
First submitted
28 Jan 2022
Last updated
9 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK112, AK117 and Carboplatin in people with Advanced Malignant Tumors, run by Akeso at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with Adverse Events (AEs) (time frame: Up to approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05229497.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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