Advanced Solid TumorsPhase 1NCT05800964
Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
A Phase 1 study testing AMG 305 in people with Advanced Solid Tumors, run by Amgen at 27 sites in 9 countries.
Trial summary
The primary objective of this study is to: Evaluate the safety and tolerability of AMG 305 in adult participants Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose Determine… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- AMG 305
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 27 sitesin 9 countries
- Study dates
- 13 Jun 2023to 22 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has provided informed consent to the main study prior to initiation of any study specific activities/procedures
- Male or female participants age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Participants with histologically or cytologically documented selected solid tumor diseases. Participants must have exhausted available standard of care (SOC) systemic therapy or must not be candidates for such available therapy
- For dose expansion cohorts: participants with at least 1 measurable lesion ≥10 mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study
- Life expectancy > 3 months
- Adequate organ function
Who cannot join
- Untreated central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
- History of other malignancy within the past 2 years
- Ongoing or active infection (including chronic or localized)
- Any pleural effusion or pericardial effusion within 4 weeks or ascites requiring recurrent drainage procedures or other medical intervention within 2 weeks prior to the first dose of the investigational products.
- Known interstitial lung disease
- Positive test for human immunodeficiency virus (HIV)
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- Positive hepatitis B surface antigen or positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR)
- History of non-infectious/immune-checkpoint inhibitor related pneumonitis that required corticosteroids, or current or suspected pneumonitis that cannot be ruled out by imaging at screening.
- Anticancer therapies including radiotherapy (with the exception of palliative radiation) chemotherapy or molecularly targeted treatments or tyrosine kinase inhibitors (TKI) within 4 weeks of administration of the first dose of AMG 305; checkpoint inhibitor therapy within 3 months of the first dose of AMG 305; or other immunotherapies/monoclonal antibodies within 3 weeks of administration of the first dose of AMG 305.
- Has had a major surgery within 4 weeks of administration of a first dose of study treatment
- Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study (eg, ulcerative colitis, Crohn's disease)
- Live and/or live-attenuated vaccines received within 28 days (or longer, if required locally) prior to the first dose of AMG 305
- Participants with unresolved toxicities from prior anti-tumor therapies to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 or better, with the exception of alopecia and grade 2 peripheral neuropathy, which has been unchanged within the last 2 months and there is agreement to allow by both the investigator and sponsor
- Currently receiving treatment in another investigational device or drug study
- Female participants of childbearing potential or male participants unwilling to use protocol specified method of contraception
- Females who are pregnant, breastfeeding or who plan to breastfeed or become pregnant while on study
- History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion
Trial locations and contacts
27 sites in 9 countries.
27 sites in 9 countries
United States6 sites
City of Hope National Medical Center
Duarte, California, 91010
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
New York University Cancer Institute
New York, New York, 10016
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Next Oncology
San Antonio, Texas, 78229
United Kingdom6 sites
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Sarah Cannon Research Institute UK
London, W1G 6AD
University College London Hospital
London, W1T 7HA
Christie Hospital
Manchester, M20 4BX
Freeman Hospital
Newcastle, NE7 7DN
Royal Marsden Hospital
Sutton, SM2 5PT
Spain4 sites
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Madrid Sanchinarro
Madrid, 28050
Germany3 sites
Universitaetsklinikum Dresden
Dresden, 01307
Universitaetsklinikum Essen
Essen, 45147
Universitaetsklinikum Wuerzburg
Würzburg, 97078
Australia2 sites
Chris OBrien Lifehouse
Camperdown, New South Wales, 2050
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
France2 sites
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059
Gustave Roussy
Villejuif, 94805
South Korea2 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
About this study
Official title: Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
The primary objective of this study is to:
- Evaluate the safety and tolerability of AMG 305 in adult participants
- Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose
- Determine the recommended phase 2 dose (RP2D)
- Conditions
- Advanced Solid Tumors
- Being tested
- AMG 305
- Keywords
- Safety, Tolerability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 305Drug
Short-term intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose Exploration | Experimental | Participants will receive escalating doses of AMG 305. Receives: Drug: AMG 305 |
| Part B: Dose Expansion | Experimental | Participants with selected solid tumors will receive the RP2D identified in Part A. Receives: Drug: AMG 305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs)
Measured: Day 1 to Day 28
Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)
Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests, as assessed by the investigator, will also be reported as TEAEs.
Measured: Up to a maximum of 2 years
Percentage of Participants who Experience Treatment-Related Adverse Events
Measured: Up to a maximum of 2 years
Secondary outcomes (10)
Maximum Serum Concentration (Cmax) of AMG 305
Measured: Up to a maximum of 2 years
Minimum Serum Concentration (Cmin) of AMG 305
Measured: Up to a maximum of 2 years
Area Under the Concentration-Time Curve (AUC) of AMG 305
Measured: Up to a maximum of 2 years
Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
ORR is defined as best overall response (BOR) of complete response (CR) or partial response (PR), Clinical Benefit Rate (defined as BOR of CR, PR, or stable disease [SD] with duration of 24 weeks or longer) based on RECIST v1.1.
Measured: Up to a maximum of 2 years
ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
ORR is defined as immune best overall response (iBOR) of immune complete response (iCR) or immune partial response (iPR), Clinical Benefit Rate (defined as iBOR of iCR, iPR, or immune stable disease [iSD] with duration of 24 weeks or longer) based on iRECIST.
Measured: Up to a maximum of 2 years
Duration of Response (DOR)
DOR is defined as the time from the first documentation of objective response until the first documentation of disease progression or death due to any cause, whichever occurs first) by RECIST v1.1 and iRECIST.
Measured: Up to a maximum of 2 years
Time to Progression
Time to progression is defined as the time rom first AMG 305 dose until the first documentation of radiological disease progression by RECIST v1.1 and iRECIST.
Measured: Up to a maximum of 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from first AMG 305 dose until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first) by RECIST v1.1 and iRECIST.
Measured: Up to a maximum of 2 years
Overall Survival (OS) at 1 Year
Measured: 1 year
OS at 2 Years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start13 Jun 2023
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800964
- Sponsor's protocol ID
- 20220073
- Other IDs
- 2022-502867-39
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05800964
- Acronym / sponsor ID
- 20220073
- Conditions
- Advanced Solid Tumors
- Keywords
- Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 37 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to:
- Evaluate the safety and tolerability of AMG 305 in adult participants
- Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose
- Determine the recommended phase 2 dose (RP2D)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Dose Exploration | Experimental | Drug: AMG 305Participants will receive escalating doses of AMG 305. |
| Part B: Dose Expansion | Experimental | Drug: AMG 305Participants with selected solid tumors will receive the RP2D identified in Part A. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant has provided informed consent to the main study prior to initiation of any study specific activities/procedures
- Male or female participants age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Participants with histologically or cytologically documented selected solid tumor diseases. Participants must have exhausted available standard of care (SOC) systemic therapy or must not be candidates for such available therapy
- For dose expansion cohorts: participants with at least 1 measurable lesion ≥10 mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study
Key exclusion criteria (17 listed)
- Untreated central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
- History of other malignancy within the past 2 years
- Ongoing or active infection (including chronic or localized)
- Any pleural effusion or pericardial effusion within 4 weeks or ascites requiring recurrent drainage procedures or other medical intervention within 2 weeks prior to the first dose of the investigational products.
- Known interstitial lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 305Short-term intravenous (IV) infusion | Drug | Part A: Dose Exploration, Part B: Dose Expansion |
Primary outcome
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs)
Time frame: Day 1 to Day 28
Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to a maximum of 2 years
Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests, as assessed by the investigator, will also be reported as TEAEs.
Percentage of Participants who Experience Treatment-Related Adverse Events
Time frame: Up to a maximum of 2 years
10 secondary outcomes
Maximum Serum Concentration (Cmax) of AMG 305
Time frame: Up to a maximum of 2 years
Minimum Serum Concentration (Cmin) of AMG 305
Time frame: Up to a maximum of 2 years
Area Under the Concentration-Time Curve (AUC) of AMG 305
Time frame: Up to a maximum of 2 years
Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Up to a maximum of 2 years
ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Time frame: Up to a maximum of 2 years
Duration of Response (DOR)
Time frame: Up to a maximum of 2 years
Time to Progression
Time frame: Up to a maximum of 2 years
Progression-Free Survival (PFS)
Time frame: Up to a maximum of 2 years
Overall Survival (OS) at 1 Year
Time frame: 1 year
OS at 2 Years
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
27 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 305 in people with Advanced Solid Tumors, run by Amgen at 27 sites in 9 countries.
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 7 inclusion and 17 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: stopped early, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, United Kingdom, Spain, Germany, Australia and 4 more countries. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) (time frame: Day 1 to Day 28). 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?
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 19 Oct 2026.