CancerPhase 1/2NCT05094804
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
A Phase 1/2 study testing OR2805, Cemiplimab and Docetaxel in people with Cancer and Tumor, Solid, run by OncoResponse, Inc. at 3 sites in United States.
Trial summary
This is an open-label, multicenter, first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR2805 administered as a monotherapy and in combination with anti-cancer agents in subjects with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Tumor, Solid, Malignant Neoplasm
- What is being tested?
- OR2805, Cemiplimab and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Sep 2021to 15 Aug 2024
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed by the subject prior to conducting study-specific procedures.
- Male or female subjects ≥ 18 and ≤ 100 years of age.
- Histological diagnosis as follows:
- Part A (dose-escalation Cohorts A1-A3): histological diagnosis of any type of carcinoma, sarcoma, or melanoma with progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy.
- Part B (expansion Cohorts B1-B3): histological diagnosis of the relevant tumor type (NSCLC or melanoma) with advanced/metastatic disease not amenable to local therapy.
- Part C (biology cohort): histological or cytological diagnosis of any type of carcinoma, sarcoma, or melanoma with progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy. At least 10 subjects each must have a diagnosis of SCCHN, dedifferentiated liposarcoma, or leiomyosarcoma with prior treatment described below.
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- Prior therapies:
- Part A (dose-escalation) i. Subjects must have experienced PD on an established standard systemic anti-cancer therapy for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds. Subjects must have no available proven curative or life-prolonging therapies.
- Part B (dose-expansion) i. Part B1 subjects (NSCLC) must have received platinum-based therapy, unless contraindicated, and a PD-1 or PD-L1 inhibitor. Subjects eligible for targeted therapies to EGFR, ALK, ROS, RET or NTRK (e.g., crizotinib) must have previously received and exhausted such therapies. Prior therapies may have been administered alone or in combination. Subjects must have received prior PD-(L)1-based therapy as the most recent prior therapy and demonstrated progression while on that therapy.
- Part B2 subjects (NSCLC) must have received platinum-based therapy and a PD-1 or PD-L1 inhibitor unless contraindicated. Subjects eligible targeted therapies to EGFR, ALK, ROS, RET or NTRK (e.g., crizotinib) must have exhausted such therapies. Prior therapies may have been administered alone or in combination. Part B2 subjects may have received a total of 3 lines of prior therapy and are not required to have received a PD-(L)1-based therapy as the most recent therapy.
- For melanoma: subjects must have received a PD-1 inhibitor, alone or in combination with another immunotherapy. Eligible subjects may have received BRAF- and MEK-targeted therapies. Subjects must have received prior PD-1-based therapy as the most recent therapy and demonstrated radiographic progression while on that therapy.
- Part C (biology cohort): subjects other than those with liposarcoma, leiomyosarcoma, or SCCHN must have experienced PD on an established standard medical anti-cancer therapy for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds and must have no available demonstrated curative or life-prolonging therapies. Subjects with liposarcoma must have dedifferentiated liposarcoma, have received at least 1 prior systemic therapy, and require additional treatment. For leiomyosarcoma, subjects must have received at least 1 prior therapy for advanced or metastatic disease. For SCCHN, subjects must have received 1 prior line of chemotherapy and a PD-1- or PD-L1-targeted agent alone or in combination with chemotherapy unless contraindicated. No more than 2 chemotherapy regimens in the advanced setting for SCCHN are allowed. All subjects must have demonstrated progression on the most recent line of therapy.
- Subjects must have measurable disease per RECIST v1.1. Subjects in Part C must have at least one 1 lesion amenable to biopsy and that is not to be used for response assessment per RECIST v1.1.
- If not postmenopausal or surgically sterile, subjects must be willing to practice at least one of the following highly effective methods of birth control for at least a menstrual cycle (or partner's menstrual cycle, for male subjects) before and for 3 months after study medication administration: (1) true abstinence, when this is in line with the preferred and usual lifestyle of the subject, from sexual intercourse with a member of the opposite sex; (2) sexual intercourse with vasectomized male/sterilized female partner; (3) hormonal female contraceptive (oral, parenteral, intravaginal, implantable, or transdermal) for at least 3 consecutive months prior to investigational product administration (when not clinically contraindicated as in breast, ovarian, and endometrial cancers); (4) use of an intrauterine contraceptive device or intrauterine hormone-releasing system.
- Resolution of prior-therapy-related AEs (excluding alopecia and grade ≤ 2 peripheral neuropathy) to ≤ grade 1 per CTCAE v5.0, and no treatment for these AEs for at least 2 weeks prior to the time of enrollment. Electrolyte and hormonal supplementation may be used to treat these AEs provided the subject is stable on these supplements.
- Minimum of 2 weeks since the last dose of other hormone therapy and 3 weeks since the last dose of other systemic cancer therapy or radiotherapy (> 4 weeks in case of nitrosoureas or radio-immuno conjugate therapy). Adjuvant hormonal therapy (for example tamoxifen) is allowed provided the original tumor diagnosis was more than 3 years before the first dose of study medication.
- Subjects must have adequate organ function.
- All subjects must be able to supply an archival tumor biopsy specimen. For Part C (biology cohort), subjects must consent to a newly obtained tumor biopsy (that can be biopsied based on Investigator's assessment) and to providing the acquired tissue for biomarker analysis. An additional on-treatment biopsy is required for subjects in Part C.
- Subject is able and willing to comply with the protocol and the restrictions and assessments therein.
Who cannot join
- Subject previously had a severe hypersensitivity reaction to treatment with another mAb.
- Subject has ECOG PS > 2.
- Life expectancy <12 weeks.
- Prior organ or stem cell transplant.
- Subjects with symptomatic ascites or pleural effusion.
- Subject has a known active CNS primary tumor or metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no radiological evidence of new or enlarging brain metastases, and are off steroids or on a stable dose up to an equivalent of prednisone 10 mg/day for at least 15 days prior to first dose of study medication. Subjects who have symptoms consistent with CNS metastasis, must have a negative MRI during in the screening period.
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- Subject has a known history of a hematologic malignancy, malignant primary brain tumor, or another malignant primary solid tumor (other than that under study), unless the subject has undergone potentially curative therapy with no evidence of that disease for at least 3 years.
- Recent or ongoing serious infection including the following:
- Any uncontrolled grade 3 or higher (per CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of OR2805. Routine antimicrobial prophylaxis is allowed.
- Uncontrolled infection with HIV. Subjects on stable HARRT therapy with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required.
- Known to be positive for hepatitis B surface antigen, or any other positive test for hepatitis B indicating acute or chronic infection. Subjects who are or have received anti-HBV therapy and have undetectable HBV DNA for at least 6 months prior to study entry are eligible.
- Known active hepatitis C as determined by positive serology and confirmed by PCR. Subjects on or having received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry.
- Known active or latent tuberculosis (testing at screening is not required).
- Autoimmune disease or inflammatory condition requiring systemic therapy with exceptions as noted in exclusion criterion 10.
- Use of systemic corticosteroids within 15 days or other immunosuppressive drugs within 30 days prior to start of the study, with the exception of corticosteroids as replacement therapy up to an equivalent of prednisone 10 mg/day which are allowed. Pretreatment with dexamethasone is allowed for subjects receiving OR2805 in combination with docetaxel. Inhaled, topical, or intraarticular steroids are allowed.
- Subject has received an investigational product or been treated with an investigational device within 30 days prior to first administration of study medication.
- For Part B:
- Known contraindication to receiving cemiplimab.
- Interstitial lung disease.
- Prior pneumonitis requiring systemic corticosteroid therapy.
- Receiving immunosuppressive therapy, with exceptions as noted in exclusion criterion 10.
- A history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any grade 4 toxicity or grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent) for more than 12 weeks.
- Concurrent therapy with anti-cancer or anti-neoplastic drugs, with the exception of adjuvant hormonal therapy, which is allowed provided the subject has undergone potentially curative therapy with no evidence of disease for at least 3 years.
- History or clinical evidence of any surgical or medical condition that the Investigator judges as likely to interfere with the results of the study or pose an additional risk in participating, e.g., rapidly progressive or uncontrolled disease involving a major organ system-vascular, cardiac, pulmonary, gastrointestinal, gynecologic, hematologic, neurologic, neoplastic, renal, endocrine, autoimmune or an immunodeficiency, or clinically significant active psychiatric or abuse disorders.
- Subjects who, at the time of signing informed consent, had a recent history (within the last year) of chronic substance abuse.
- Subject is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
NEXT Austin
Austin, Texas, 78758
Andrae Vandross, MD, 210-580-9500, avandross@nextoncology.com
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
Anthony W Tolcer, MD, 210-580-9500, atolcher@nextoncology.com
- Recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Michael S Gordon, MD, 480-323-1350, mgordon@honorhealth.com
About this study
Official title: A Phase 1-2 Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents in Subjects With Advanced Malignancies
This is an open-label, multicenter, first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR2805 administered as a monotherapy and in combination with anti-cancer agents in subjects with advanced solid tumors.
Read the detailed description
This Phase 1-2 study is designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR2805, a fully human IgG1 antibody that binds specifically to CD163, in subjects with advanced solid tumors. The study consists of three parts:
- Part A: a dose-escalation phase to determine the maximum-tolerated dose (MTD), maximum achievable dose, or recommended phase 2 dose (RP2D) of OR2805 given alone or in combination with cemiplimab or docetaxel in a maximum of approximately 54 subjects.
- Part B: an expansion phase in subjects with melanoma or non-small cell lung cancer (NSCLC) treated with OR2805 as monotherapy at the RP2D or OR2805 in combination with cemiplimab or docetaxel. Up to approximately 20 subjects will be treated in each arm of the 3 Part B cohorts to further characterize safety and determine the preliminary anti-tumor activity.
- Part C: a biology cohort of up to approximately 40 subjects at the RP2D to determine the mechanism of action and potential predictors of response and pharmacodynamic markers in subjects with liposarcoma, leiomyocarcoma, or squamous cell carcinoma of the head and neck (SCCHN) or are not otherwise eligible for Part B. All subjects in Part C will undergo biopsies.
- Conditions
- Cancer, Tumor, Solid, Malignant Neoplasm, Metastatic Cancer, Advanced Solid Tumor, Non Small Cell Lung Cancer
- Being tested
- OR2805, Cemiplimab, Docetaxel
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Melanoma, Squamous Cell Carcinoma of Head and Neck, Leiomyosarcoma, Liposarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OR2805Drug
IgG1 monoclonal antibody that binds specifically to the CD163 protein.
CemiplimabDrug
Also called Libtayo
IgG4 mAb that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2.
DocetaxelDrug
Also called Taxotere
An antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.
| Study group | Role | What they receive |
|---|---|---|
| OR2805 monotherapy and combination therapy dose-escalation phase (Part A) | Experimental | Escalating repeated doses of OR2805 by IV administration as monotherapy or in combination with cemiplimab or docetaxel in subjects with advanced solid tumors. OR2805 will be administered once every 3 weeks (Q3W) or once-weekly (QW) for 3 weeks as an IV infusion over 30 minutes.
Cemiplimab will be administered as an IV infusion at a dose of 350 mg.
Docetaxel will be administered as an IV infusion at a dose of 75 mg/m2. Receives: Drug: OR2805; Drug: Cemiplimab; Drug: Docetaxel |
| OR2805 monotherapy and combination therapy dose-expansion phase (Part B) | Experimental | OR2805 administered IV at the RP2D and dosing regimen identified in Part A as monotherapy or in combination with cemiplimab or docetaxel in subjects with NSCLC and melanoma.
Cemiplimab will be administered as an IV infusion at a dose of 350 mg.
Docetaxel will be administered as an IV infusion at a dose of 75 mg/m2. Receives: Drug: OR2805; Drug: Cemiplimab; Drug: Docetaxel |
| OR2805 biological effects phase (Part C) | Experimental | OR2805 administered IV at the RP2D and dosing regimen identified in Part A as monotherapy to determine the mechanism of action and potential predictors of response and pharmacodynamic markers in subjects with liposarcoma, leiomyosarcoma, or SCCHN or are not otherwise eligible for Cohort B. Receives: Drug: OR2805 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity
The incidence of DLTs during the DLT assessment period.
Measured: First 21 days of treatment.
Safety and Tolerability
The nature, frequency, and severity of adverse events and serious adverse events, treatment discontinuations due to toxicity, and clinical laboratory abnormalities; recording of infusion-related reactions; physical examination and ECG findings; vital sign measurements; ECOG performance status scores; markers of inflammation and immunogenicity.
Measured: Screening to 90 days from last dose.
Recommended Dose and Regimen (mono and combination therapy)
Determination of the MTD or maximum achievable dose, and the RP2D.
Measured: Screening to 90 days from last dose.
Secondary outcomes (5)
Pharmacokinetics of OR2805
Peak plasma concentration (Cmax).
Measured: Day 1 of dosing through 21 days post last dose.
Pharmacokinetics of OR2805
Area under the plasma concentration versus time curve (AUC).
Measured: Day 1 of dosing through 21 days post last dose.
Objective Response Rate (ORR)
ORR according to RECIST v1.1.
Measured: Day 1 of dosing through every 90 after the last dose.
Disease Control Rate (DCR)
The percentage of subjects with a complete response, partial response, or stable disease for at least 2 consecutive tumor assessments.
Measured: Day 1 of dosing through every 90 after the last dose.
Progression Free Survival (PFS)
Time from the date of initiation of study therapy to the date measurement criteria are first met for PD or death from any cause, whichever occurs first.
Measured: Day 1 of dosing through every 90 after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start9 Sep 2021
- Primary completion15 Apr 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncoResponse, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094804
- Sponsor's protocol ID
- OR2805-101
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2021
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1-2 Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT05094804
- Acronym / sponsor ID
- OR2805-101
- Conditions
- Cancer, Tumor, Solid, Malignant Neoplasm, Metastatic Cancer, Advanced Solid Tumor, Non Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- OncoResponse, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 26 Oct 2021 (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.
This is an open-label, multicenter, first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR2805 administered as a monotherapy and in combination with anti-cancer agents in subjects with advanced solid tumors.
Detailed description
This Phase 1-2 study is designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR2805, a fully human IgG1 antibody that binds specifically to CD163, in subjects with advanced solid tumors. The study consists of three parts:
- Part A: a dose-escalation phase to determine the maximum-tolerated dose (MTD), maximum achievable dose, or recommended phase 2 dose (RP2D) of OR2805 given alone or in combination with cemiplimab or docetaxel in a maximum of approximately 54 subjects.
- Part B: an expansion phase in subjects with melanoma or non-small cell lung cancer (NSCLC) treated with OR2805 as monotherapy at the RP2D or OR2805 in combination with cemiplimab or docetaxel. Up to approximately 20 subjects will be treated in each arm of the 3 Part B cohorts to further characterize safety and determine the preliminary anti-tumor activity.
- Part C: a biology cohort of up to approximately 40 subjects at the RP2D to determine the mechanism of action and potential predictors of response and pharmacodynamic markers in subjects with liposarcoma, leiomyocarcoma, or squamous cell carcinoma of the head and neck (SCCHN) or are not otherwise eligible for Part B. All subjects in Part C will undergo biopsies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OR2805 monotherapy and combination therapy dose-escalation phase (Part A) | Experimental | Drug: OR2805, Drug: Cemiplimab, Drug: DocetaxelEscalating repeated doses of OR2805 by IV administration as monotherapy or in combination with cemiplimab or docetaxel in subjects with advanced solid tumors. OR2805 will be administered once every 3 weeks (Q3W) or once-weekly (QW) for 3 weeks as an IV infusion over 30 minutes. Cemiplimab will be administered as an IV infusion at a dose of 350 mg. Docetaxel will be administered as an IV infusion at a dose of 75 mg/m2. |
| OR2805 monotherapy and combination therapy dose-expansion phase (Part B) | Experimental | Drug: OR2805, Drug: Cemiplimab, Drug: DocetaxelOR2805 administered IV at the RP2D and dosing regimen identified in Part A as monotherapy or in combination with cemiplimab or docetaxel in subjects with NSCLC and melanoma. Cemiplimab will be administered as an IV infusion at a dose of 350 mg. Docetaxel will be administered as an IV infusion at a dose of 75 mg/m2. |
| OR2805 biological effects phase (Part C) | Experimental | Drug: OR2805OR2805 administered IV at the RP2D and dosing regimen identified in Part A as monotherapy to determine the mechanism of action and potential predictors of response and pharmacodynamic markers in subjects with liposarcoma, leiomyosarcoma, or SCCHN or are not otherwise eligible for Cohort B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Informed consent signed by the subject prior to conducting study-specific procedures.
- Male or female subjects ≥ 18 and ≤ 100 years of age.
- Histological diagnosis as follows:
- Prior therapies:
- Subjects must have measurable disease per RECIST v1.1. Subjects in Part C must have at least one 1 lesion amenable to biopsy and that is not to be used for response assessment per RECIST v1.1.
Key exclusion criteria (26 listed)
- Subject previously had a severe hypersensitivity reaction to treatment with another mAb.
- Subject has ECOG PS > 2.
- Life expectancy <12 weeks.
- Prior organ or stem cell transplant.
- Subjects with symptomatic ascites or pleural effusion.
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 |
|---|---|---|
| OR2805IgG1 monoclonal antibody that binds specifically to the CD163 protein. | Drug | OR2805 biological effects phase (Part C), OR2805 monotherapy and combination therapy dose-escalation phase (Part A), OR2805 monotherapy and combination therapy dose-expansion phase (Part B) |
| CemiplimabAlso: LibtayoIgG4 mAb that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2. | Drug | OR2805 monotherapy and combination therapy dose-escalation phase (Part A), OR2805 monotherapy and combination therapy dose-expansion phase (Part B) |
| DocetaxelAlso: TaxotereAn antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. | Drug | OR2805 monotherapy and combination therapy dose-escalation phase (Part A), OR2805 monotherapy and combination therapy dose-expansion phase (Part B) |
Primary outcome
Dose-limiting Toxicity
Time frame: First 21 days of treatment.
The incidence of DLTs during the DLT assessment period.
Safety and Tolerability
Time frame: Screening to 90 days from last dose.
The nature, frequency, and severity of adverse events and serious adverse events, treatment discontinuations due to toxicity, and clinical laboratory abnormalities; recording of infusion-related reactions; physical examination and ECG findings; vital sign measurements; ECOG performance status scores; markers of inflammation and immunogenicity.
Recommended Dose and Regimen (mono and combination therapy)
Time frame: Screening to 90 days from last dose.
Determination of the MTD or maximum achievable dose, and the RP2D.
5 secondary outcomes
Pharmacokinetics of OR2805
Time frame: Day 1 of dosing through 21 days post last dose.
Pharmacokinetics of OR2805
Time frame: Day 1 of dosing through 21 days post last dose.
Objective Response Rate (ORR)
Time frame: Day 1 of dosing through every 90 after the last dose.
Disease Control Rate (DCR)
Time frame: Day 1 of dosing through every 90 after the last dose.
Progression Free Survival (PFS)
Time frame: Day 1 of dosing through every 90 after the last dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OR2805, Cemiplimab and Docetaxel in people with Cancer and Tumor, Solid, run by OncoResponse, Inc. at 3 sites in United States.
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 19 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kate Harrop (425-420-0749, KHarrop@oncoresponseinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicity (time frame: First 21 days of treatment.). 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 2 Nov 2023.