A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours

Inclusion criteria:

• Participant must be ≥18 years of age, at the time of signing the informed consent.

• Participants with histologically or cytologically documented, locally advanced, ormetastatic solid tumors, that relapsed or were refractory after being previouslytreated with standard of care therapy; or for which there is no availableestablished therapy; or standard therapy is contraindicated or not deemedappropriate by the treating investigator.

• Participants must have measurable disease per Response Evaluation Criteria in SolidTumours (RECIST) version 1.1.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

• Male and female participants Contraceptive use by men or women should be consistentwith local regulations regarding the methods of contraception for thoseparticipating in clinical studies.

• Adequate bone marrow function within 7 days before first dose of study intervention,

• Adequate renal function within 7 days before first dose of study intervention,

• Adequate hepatic function or laboratory abnormalities indicating hepatic injurywithin 7 days before first dose of study intervention,

• Prothrombin time or international normalised ratio (INR) ≤1.5 × ULN.

• At the time of screening, a tumour tissue specimen is required for enrolment intothe dose escalation and dose optimisation portions of the study for retrospectivecentral laboratory determination.

• Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the informed consent form (ICF).

• Have a life expectancy of more than 3 months for disease-related mortality, asevaluated by the investigator.

Exclusion Criteria:

• Known second malignancy either progressing or requiring active treatment within thelast 2 years prior to first dose of study intervention.

• Residual toxicity from prior anticancer therapy that are NCI CTCAE version 5.0 Grade 2 or higher. Stable chronic Grade 2 toxicities from previous treatments may beeligible per the judgement of investigator.

• History of major surgery within 4 weeks prior to the first dose of studyintervention.

• Previous solid organ transplantation.

• Pre-existing, acute or chronic severe corneal disorders, sequelae from severecorneal disorders, or a history of corneal transplantation.

• Active brain metastases or leptomeningeal metastases with exception to asymptomaticand treated brain metastases (i.e. no neurological symptoms, no requirements forcorticosteroids and lesions <1.5 cm), which are stable and not expected to becomesymptomatic in the next 3 months in the opinion of the investigator.

• History of stroke or significant cerebrovascular disease (ie, transient ischemicattack) within 6 months prior to initiation of study intervention.

• History of clinically significant cardiac disease within 6 months prior to theinitiation of study intervention, including but not limited to unstable angina,acute myocardial infarction, endoscopic or open-heart cardiac surgery, or heartfailure classified as New York Heart Association Grade 2 or higher.

• History of clinically significant respiratory disease within 6 months prior to theinitiation of study intervention, including severe chronic obstructive pulmonarydisease or asthma.

• History of noninfectious interstitial lung disease (ILD)/pneumonitis/radiationpneumonitis that required steroids or has current ILD/pneumonitis.

• Clinically significant gastrointestinal disorder including bleeding, occlusion,diarrhoea >Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory boweldisease or partial bowel obstruction.

• Any evidence of severe active infection or inflammatory condition.

• Significant concurrent, uncontrolled medical condition that would put participantsat unacceptable risk from study participation or preclude them from complying withstudy procedures as per investigator assessment, including, but not limited torenal, hepatic, haematological, gastrointestinal, endocrine, pulmonary,neurological, cerebral, or psychiatric disease.

• Participants with uncontrolled human immunodeficiency virus (HIV). HIV infectedparticipants are eligible if they meet criteria described in the protocol.

• Known active infection with hepatitis B virus (HBV) OR hepatitis C virus (HCV).Participants are eligible if they meet criteria described in the protocol.

• Ongoing immunosuppressive therapy, including systemic corticosteroids. NOTE:Physiologic replacement or use of topical or inhaled corticosteroids are allowed.

• Concurrent participation in another therapeutic treatment trial, previousparticipation should respect the minimum of 5 half-lives or 4 weeks before the studyintervention initiation (whichever is shorter).

• Participants accommodated in an institution because of regulatory or legal order;prisoners or participants who are legally institutionalised.

• For French participants only: participants are under court protection, notaffiliated to a social security system or protected adults.